P-CARE X- lidocaine hydrochloride, sodium chloride, povidone-iodine, isopropyl alcohol kit

United States - English - NLM (National Library of Medicine)

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Active ingredient:
LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987)
Available from:
RX PHARMA-PACK, INC.
INN (International Name):
LIDOCAINE HYDROCHLORIDE ANHYDROUS
Composition:
LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg in 1 mL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Lidocaine HCl is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type. Sodium Chloride Injection, USP, 0.9% preparations are indicated for diluting or dissolving drugs for intramuscular, intravenous or subcutaneous injection according to instructions of the manufacturer of the drug to be administered. Sodium Chloride Injection, USP, 0.9% is also indicated for use in flushing of intravenous catheters. Antiseptic Antiseptic skin preparation Antiseptic For preparation of the skin prior to injection.
Product summary:
Xylocaine® (lidocaine HCl Injection, USP) NDC 63323-484-57 Unit of 25 NDC 63323-485-27 Unit of 25 NDC 63323-485-57 Unit of 25 NDC 63323-486-17 Unit of 25 NDC 63323-486-27 Unit of 25 NDC 63323-486-57 Unit of 25 Xylocaine® -MPF (lidocaine HCl Injection, USP) Xylocaine® (lidocaine HCl and epinephrine Injection, USP) with Epinephrine 1:100,000  Xylocaine® (lidocaine HCl and epinephrine Injection, USP) with Epinephrine 1:200,000  Xylocaine® -MPF (lidocaine HCl and epinephrine Injection, USP) with Epinephrine 1:200,000 For single-dose vials and ampules: Discard unused portion. All solutions should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. All trademarks are the property of Fresenius Kabi USA, LLC.  Fresenius Kabi Logo www.fresenius-kabi.com/us 4 5 1 1 7 5 F Revised: March 2019 Sodium Chloride Injection, USP, 0.9%, preservative free, is available as follows: NDC 63323-186-04 2 mL fill, in a 3 mL Single-Dose Vial NDC 63323-186-01 10 mL Single-Dose vial NDC 63323-186-03 20 mL Single-Dose vial Preservative Free. Discard unused portion. Use only if solution is clear and seal intact. Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Fresenius Kabi Logo www.fresenius-kabi.com/us 45764E Revised: October 2018
Authorization status:
New Drug Application
Authorization number:
49836-003-18

P-CARE X- lidocaine hydrochloride, sodium chloride, povidone-iodine, isopropyl alcohol

RX PHARMA-PACK, INC.

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P-Care X

Xylocaine - lidocaine hydrochloride injection, solution

XYLOCAINE MPF- lidocaine hydrochloride injection, solution

XYLOCAINE - lidocaine hydrochloride injection, solution

XYLOCAINE MPF- lidocaine hydrochloride, epinephrine bitartrate injection, solution

XYLOCAINE - lidocaine hydrochloride, epinephrine bitartrate injection, solution

Fresenius Kabi USA, LLC

Xylocaine

(lidocaine HCl Injection, USP)

Xylocaine

(lidocaine HCl and epinephrine Injection, USP)

For Infiltration and Nerve Block

Rx only

DESCRIPTION

Xylocaine (lidocaine HCl) Injections are sterile, nonpyrogenic, aqueous solutions that contain a local

anesthetic agent with or without epinephrine and are administered parenterally by injection. See

INDICATIONS AND USAGE section for specific uses.

Xylocaine solutions contain lidocaine HCl, which is chemically designated as acetamide, 2-

(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular wt. 270.8. Lidocaine

HCl (C

HCl) has the following structural formula:

Xylocaine Structural Formula

Epinephrine is (-) -3, 4-Dihydroxy-α-[(methylamino) methyl] benzyl alcohol and has the molecular wt.

183.21. Epinephrine (C H NO ) has the following structural formula:

Epinephrine Structural Formula

®

®

Dosage forms listed as Xylocaine-MPF indicate single dose solutions that are Methyl Paraben Free

(MPF).

Xylocaine MPF is a sterile, nonpyrogenic, isotonic solution containing sodium chloride.

Xylocaine in multiple dose vials: Each mL also contains 1 mg methylparaben as antiseptic preservative.

The pH of these solutions is adjusted to approximately 6.5 (5.0 to 7.0) with sodium hydroxide and/or

hydrochloric acid.

Xylocaine MPF with Epinephrine is a sterile, nonpyrogenic, isotonic solution containing sodium

chloride. Each mL contains lidocaine hydrochloride and epinephrine, with 0.5 mg sodium metabisulfite

as an antioxidant and 0.2 mg citric acid as a stabilizer.

Xylocaine with Epinephrine in multiple dose vials: Each mL also contains 1 mg methylparaben as

antiseptic preservative.

The pH of these solutions is adjusted to approximately 4.5 (3.3 to 5.5) with sodium hydroxide and/or

hydrochloric acid. Filled under nitrogen.

CLINICAL PHARMACOLOGY

Mechanism of Action

Lidocaine HCl stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation

and conduction of impulses thereby effecting local anesthetic action.

Hemodynamics

Excessive blood levels may cause changes in cardiac output, total peripheral resistance, and mean

arterial pressure. With central neural blockade these changes may be attributable to block of autonomic

fibers, a direct depressant effect of the local anesthetic agent on various components of the

cardiovascular system, and/or the beta-adrenergic receptor stimulating action of epinephrine when

present. The net effect is normally a modest hypotension when the recommended dosages are not

exceeded.

Pharmacokinetics and Metabolism

Information derived from diverse formulations, concentrations and usages reveals that lidocaine HCl is

completely absorbed following parenteral administration, its rate of absorption depending, for example,

upon various factors such as the site of administration and the presence or absence of a vasoconstrictor

agent. Except for intravascular administration, the highest blood levels are obtained following

intercostal nerve block and the lowest after subcutaneous administration.

The plasma binding of lidocaine HCl is dependent on drug concentration, and the fraction bound

decreases with increasing concentration. At concentrations of 1 to 4 mcg of free base per mL 60 to 80

percent of lidocaine HCl is protein bound. Binding is also dependent on the plasma concentration of the

alpha-1-acid glycoprotein.

Lidocaine HCl crosses the blood-brain and placental barriers, presumably by passive diffusion.

Lidocaine HCl is metabolized rapidly by the liver, and metabolites and unchanged drug are excreted by

the kidneys. Biotransformation includes oxidative N-dealkylation, ring hydroxylation, cleavage of the

amide linkage, and conjugation. N-dealkylation, a major pathway of biotransformation, yields the

metabolites monoethylglycinexylidide and glycinexylidide. The pharmacological/toxicological actions

of these metabolites are similar to, but less potent than, those of lidocaine HCl. Approximately 90% of

lidocaine HCl administered is excreted in the form of various metabolites, and less than 10% is

excreted unchanged. The primary metabolite in urine is a conjugate of 4-hydroxy-2,6-dimethylaniline.

The elimination half-life of lidocaine HCl following an intravenous bolus injection is typically 1.5 to 2

hours. Because of the rapid rate at which lidocaine HCl is metabolized, any condition that affects liver

function may alter lidocaine HCl kinetics. The half-life may be prolonged two-fold or more in patients

with liver dysfunction. Renal dysfunction does not affect lidocaine HCl kinetics but may increase the

accumulation of metabolites.

Factors such as acidosis and the use of CNS stimulants and depressants affect the CNS levels of

lidocaine HCl required to produce overt systemic effects. Objective adverse manifestations become

increasingly apparent with increasing venous plasma levels above 6 mcg free base per mL. In the

rhesus monkey arterial blood levels of 18 to 21 mcg/mL have been shown to be threshold for

convulsive activity.

INDICATIONS AND USAGE

Xylocaine (lidocaine HCl) Injections are indicated for production of local or regional anesthesia by

infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral

nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as

lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in

standard textbooks are observed.

CONTRAINDICATIONS

Lidocaine HCl is contraindicated in patients with a known history of hypersensitivity to local

anesthetics of the amide type.

WARNINGS

XYLOCAINE INJECTIONS FOR INFILTRATION AND NERVE BLOCK SHOULD BE

EMPLOYED ONLY BY CLINICIANS WHO ARE WELL VERSED IN DIAGNOSIS AND

MANAGEMENT OF DOSE-RELATED TOXICITY AND OTHER ACUTE EMERGENCIES THAT

MIGHT ARISE FROM THE BLOCK TO BE EMPLOYED AND THEN ONLY AFTER ENSURING

THE IMMEDIATE AVAILABILITY OF OXYGEN, OTHER RESUSCITATIVE DRUGS,

CARDIOPULMONARY EQUIPMENT AND THE PERSONNEL NEEDED FOR PROPER

MANAGEMENT OF TOXIC REACTIONS AND RELATED EMERGENCIES (see also ADVERSE

REACTIONS and PRECAUTIONS). DELAY IN PROPER MANAGEMENT OF DOSE-RELATED

TOXICITY,

UNDERVENTILATION FROM ANY CAUSE AND/OR ALTERED SENSITIVITY MAY LEAD TO

THE DEVELOPMENT OF ACIDOSIS, CARDIAC ARREST AND, POSSIBLY, DEATH.

Methemoglobinemia

Cases of methemoglobinemia have been reported in association with local anesthetic use. Although all

patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase

deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants

under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more

susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in

these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended.

Signs of methemoglobinemia may occur immediately or may be delayed some hours after exposure, and

are characterized by a cyanotic skin discoloration and/or abnormal coloration of the blood.

Methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more

serious central nervous system and cardiovascular adverse effects, including seizures, coma,

arrhythmias, and death. Discontinue Xylocaine and any other oxidizing agents. Depending on the

severity of the signs and symptoms, patients may respond to supportive care, i.e., oxygen therapy,

hydration. A more severe clinical presentation may require treatment with methylene blue, exchange

transfusion, or hyperbaric oxygen.

Intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures is an

unapproved use, and there have been post-marketing reports of chondrolysis in patients receiving such

infusions. The majority of reported cases of chondrolysis have involved the shoulder joint; cases of

gleno-humeral chondrolysis have been described in pediatric and adult patients following intra-articular

infusions of local anesthetics with and without epinephrine for periods of 48 to 72 hours. There is

insufficient information to determine whether shorter infusion periods are not associated with these

findings. The time of onset of symptoms, such as joint pain, stiffness and loss of motion can be variable,

but may begin as early as the 2nd month after surgery. Currently, there is no effective treatment for

chondrolysis; patients who experienced chondrolysis have required additional diagnostic and

therapeutic procedures and some required arthroplasty or shoulder replacement.

To avoid intravascular injection, aspiration should be performed before the local anesthetic solution is

injected. The needle must be repositioned until no return of blood can be elicited by aspiration. Note,

however, that he absence of blood in the syringe does not guarantee that intravascular injection has

been avoided.

Local anesthetic solutions containing antimicrobial preservatives (e.g., methylparaben) should not be

used for epidural or spinal anesthesia because the safety of these agents has not been established with

regard to intrathecal injection, either intentional or accidental.

Xylocaine with epinephrine solutions contain sodium metabisulfite, a sulfite that may cause allergic-

type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in

certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is

unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic

people.

Anaphylactic reactions may occur following administration of lidocaine hydrochloride (see

ADVERSE REACTIONS).

In the case of severe reaction, discontinue the use of the drug.

PRECAUTIONS

General

The safety and effectiveness of lidocaine HCl depend on proper dosage, correct technique, adequate

precautions, and readiness for emergencies. Standard textbooks should be consulted for specific

techniques and precautions for various regional anesthetic procedures.

Resuscitative equipment, oxygen, and other resuscitative drugs should be available for immediate use

(see WARNINGS and ADVERSE REACTIONS). The lowest dosage that results in effective

anesthesia should be used to avoid high plasma levels and serious adverse effects. Syringe aspirations

should also be performed before and during each supplemental injection when using indwelling catheter

techniques. During the administration of epidural anesthesia, it is recommended that a test dose be

administered initially and that the patient be monitored for central nervous system toxicity and

cardiovascular toxicity, as well as for signs of unintended intrathecal administration, before

proceeding. When clinical conditions permit, consideration should be given to employing local

anesthetic solutions that contain epinephrine for the test dose because circulatory changes compatible

with epinephrine may also serve as a warning sign of unintended intravascular injection. An intravascular

injection is still possible even if aspirations for blood are negative. Repeated doses of lidocaine HCl

may cause significant increases in blood levels with each repeated dose because of slow accumulation

of the drug or its metabolites. Tolerance to elevated blood levels varies with the status of the patient.

Debilitated, elderly patients, acutely ill patients, and children should be given reduced doses

commensurate with their age and physical condition. Lidocaine HCl should also be used with caution in

patients with severe shock or heart block.

Lumbar and caudal epidural anesthesia should be used with extreme caution in persons with the

following conditions: existing neurological disease, spinal deformities, septicemia, and severe

hypertension.

Local anesthetic solutions containing a vasoconstrictor should be used cautiously and in carefully

circumscribed quantities in areas of the body supplied by end arteries or having otherwise

compromised blood supply. Patients with peripheral vascular disease and those with hypertensive

vascular disease may exhibit exaggerated vasoconstrictor response. Ischemic injury or necrosis may

result. Preparations containing a vasoconstrictor should be used with caution in patients during or

following the administration of potent general anesthetic agents, since cardiac arrhythmias may occur

under such conditions.

Careful and constant monitoring of cardiovascular and respiratory (adequacy of ventilation) vital signs

and the patient’s state of consciousness should be accomplished after each local anesthetic injection. It

should be kept in mind at such times that restlessness, anxiety, tinnitus, dizziness, blurred vision,

tremors, depression or drowsiness may be early warning signs of central nervous system toxicity.

Since amide-type local anesthetics are metabolized by the liver, Xylocaine Injection should be used

with caution in patients with hepatic disease. Patients with severe hepatic disease, because of their

inability to metabolize local anesthetics normally, are at greater risk of developing toxic plasma

concentrations. Xylocaine Injection should also be used with caution in patients with impaired

cardiovascular function since they may be less able to compensate for functional changes associated

with the prolongation of A-V conduction produced by these drugs.

Many drugs used during the conduct of anesthesia are considered potential triggering agents for

familial malignant hyperthermia. Since it is not known whether amide-type local anesthetics may trigger

this reaction and since the need for supplemental general anesthesia cannot be predicted in advance, it is

suggested that a standard protocol for the management of malignant hyperthermia should be available.

Early unexplained signs of tachycardia, tachypnea, labile blood pressure and metabolic acidosis may

precede temperature elevation. Successful outcome is dependent on early diagnosis,

prompt discontinuance of the suspect triggering agent(s) and institution of treatment, including oxygen

therapy, indicated supportive measures and dantrolene (consult dantrolene sodium intravenous package

insert before using).

Proper tourniquet technique, as described in publications and standard textbooks, is essential in the

performance of intravenous regional anesthesia. Solutions containing epinephrine or other

vasoconstrictors should not be used for this technique.

Lidocaine HCl should be used with caution in persons with known drug sensitivities. Patients allergic

to para-aminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross-

sensitivity to lidocaine HCl.

Use in the Head and Neck Area

Small doses of local anesthetics injected into the head and neck area, including retrobulbar, dental and

stellate ganglion blocks, may produce adverse reactions similar to systemic toxicity seen with

unintentional intravascular injections of larger doses. Confusion, convulsions, respiratory depression

and/or respiratory arrest, and cardiovascular stimulation or depression have been reported. These

reactions may be due to intra-arterial injection of the local anesthetic with retrograde flow to the

cerebral circulation. Patients receiving these blocks should have their circulation and respiration

monitored and be constantly observed. Resuscitative equipment and personnel for treating adverse

reactions should be immediately available. Dosage recommendations

should not be exceeded (see DOSAGE AND ADMINISTRATION).

Information for Patients

When appropriate, patients should be informed in advance that they may experience temporary loss of

sensation and motor activity, usually in the lower half of the body, following proper administration of

epidural anesthesia.

Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must

be treated promptly. Advise patients or caregivers to seek immediate medical attention if they or

someone in their care experience the following signs or symptoms: pale, gray, or blue colored skin

(cyanosis); headache; rapid heart rate; shortness of breath; lightheadedness; or fatigue.

Clinically Significant Drug Interactions

The administration of local anesthetic solutions containing epinephrine or norepinephrine to patients

receiving monoamine oxidase inhibitors or tricyclic antidepressants may produce severe, prolonged

hypertension.

Phenothiazines and butyrophenones may reduce or reverse the pressor effect of epinephrine.

Concurrent use of these agents should generally be avoided. In situations when concurrent therapy is

necessary, careful patient monitoring is essential.

Concurrent administration of vasopressor drugs (for the treatment of hypotension related to obstetric

blocks) an ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular

accidents.

Drug/Laboratory Test Interactions

The intramuscular injection of lidocaine HCl may result in an increase in creatine phosphokinase

levels. Thus, the use of this enzyme determination, without isoenzyme separation, as a diagnostic test

for the presence of acute myocardial infarction may be compromised by the intramuscular injection of

lidocaine HCl.

Patients who are administered local anesthetics are at increased risk of developing methemoglobinemia

when concurrently exposed to the following drugs, which could include other local anesthetics:

Examples of Drugs Associated with Methemoglobinemia:

Clas s

Examples

Nitrates/Nitrites

nitric oxide, nitroglycerin, nitroprusside, nitrous oxide

Local anesthetics

articaine, benzocaine, bupivacaine, lidocaine, mepivacaine,

prilocaine, procaine, ropivacaine, tetracaine

Antineoplastic agents

cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase

Antibiotics

dapsone, nitrofurantoin, paraaminosalicylic acid, sulfonamides

Antimalarials

chloroquine, primaquine

Anticonvulsants

phenobarbital, phenytoin, sodium valproate

Other drugs

acetaminophen, metoclopramide, quinine, sulfasalazine

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies of lidocaine HCl in anima s to evaluate the carcinogenic and mutagenic potential or the effect on

fertility have not been conducted.

Pregnancy

Teratogenic Effects: Pregnancy Category B.

Reproduction studies have been performed in rats at doses up to 6.6 times the human dose and have

revealed no evidence of harm to the fetus caused by lidocaine HCl. There are, however, no adequate

and well-controlled studies in pregnant women. Animal reproduction studies are not always predictive

of human response. General consideration should be given to this fact before administering lidocaine

HCl to women of childbearing potential, especially during early pregnancy when maximum

organogenesis takes place.

Labor and Delivery

Local anesthetics rapidly cross the placenta and when used for epidural, paracervical, pudendal or

caudal block anesthesia, can cause varying degrees of maternal, fetal and neonatal toxicity (see

CLINICAL PHARMACOLOGY, Pharmacokinetics and Metabolism). The potential for toxicity

depends upon

the procedure performed, the type and amount of drug used, and the technique of drug administration.

Adverse reactions in the parturient, fetus and neonate involve alterations of the central nervous system,

peripheral vascular tone and cardiac function.

Maternal hypotension has resulted from regional anesthesia. Local anesthetics produce vasodilation by

blocking sympathetic nerves. Elevating the patient’s legs and positioning her on her left side will help

prevent decreases in blood pressure. The fetal heart rate also should be monitored continuously, and

electronic fetal monitoring is highly advisable.

Epidural, spinal, paracervical, or pudendal anesthesia may alter the forces of parturition through

changes in uterine contractility or maternal expulsive efforts. In one study, paracervical block

anesthesia was associated with a decrease in the mean duration of first stage labor and facilitation of

cervical dilation. However, spinal and epidural anesthesia have also been reported to prolong the

second stage of labor by removing the parturient’s reflex urge to bear down or by interfering with

motor function. The use of obstetrical anesthesia may increase the need for forceps assistance.

The use of some local anesthetic drug products during labor and delivery may be followed by

diminished muscle strength and tone for the first day or two of life. The long-term significance of

these observations is unknown. Fetal bradycardia may occur in 20 to 30 percent of patients receiving

paracervical nerve block anesthesia with the amide-type local anesthetics and may be associated with

fetal acidosis. Fetal heart rate should always be monitored during paracervical anesthesia. The

physician should weigh the possible advantages against risks when considering a paracervical block in

prematurity, toxemia of pregnancy, and fetal distress. Careful adherence to recommended dosage is of

the utmost importance in obstetrical paracervical block. Failure to achieve adequate analgesia with

recommended doses should arouse suspicion of intravascular or fetal intracranial injection. Cases

compatible with unintended fetal intracranial injection of local anesthetic solution have been reported

following intended paracervical or pudendal block or both. Babies so affected present with

unexplained neonatal depression at birth, which correlates with high local anesthetic serum levels, and

often manifest seizures within six hours. Prompt use of supportive measures combined with forced

urinary excretion of the local anesthetic has been used successfully to manage this complication.

Case reports of maternal convulsions and cardiovascular collapse following use of some local

anesthetics for paracervical block in early pregnancy (as anesthesia for elective abortion) suggest that

systemic absorption under these circumstances may be rapid. The recommended maximum dose of each

drug should not be exceeded. Injection should be made slowly and with frequent aspiration. Allow a 5-

minute interval between sides.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human

milk, caution should be exercised when lidocaine HCl is administered to a nursing woman.

Pediatric Use

Dosages in children should be reduced, commensurate with age, body weight and physical condition

(see DOSAGE AND ADMINISTRATION).

ADVERSE REACTIONS

Systemic

Adverse experiences following the administration of lidocaine HCl are similar in nature to those

observed with other amide local anesthetic agents. These adverse experiences are, in general, dose-

related and may result from high plasma levels caused by excessive dosage, rapid absorption or

inadvertent intravascular injection, or may result from a hypersensitivity, idiosyncrasy or diminished

tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature. The

following types are those most commonly reported:

Central Nervous System

CNS manifestations are excitatory and/or depressant and may be characterized by lightheadedness,

nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double

vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions,

unconsciousness, respiratory depression and arrest. The excitatory manifestations may be very brief or

may not occur at all, in which case the first manifestation of toxicity may be drowsiness merging into

unconsciousness and respiratory arrest.

Drowsiness following the administration of lidocaine HCl is usually an early sign of a high blood level

of the drug and may occur as a consequence of rapid absorption.

Cardiovascular System

Cardiovascular manifestations are usually depressant and are characterized by bradycardia, hypotension,

and cardiovascular collapse, which may lead to cardiac arrest.

Allergic

Allergic reactions are characterized by cutaneous lesions, urticaria, edema or anaphylactoid reactions.

Allergic reactions may occur as a result of sensitivity either to local anesthetic agents or to the

methylparaben used as a preservative in the multiple dose vials. Allergic reactions, including

anaphylactic reactions, may occur as a result of sensitivity to lidocaine, but are infrequent. If allergic

reactions do occur, they should be managed by conventional means. The detection of sensitivity by skin

testing is of doubtful value.

There have been no reports of cross sensitivity between lidocaine hydrochloride and procainamide or

between lidocaine hydrochloride and quinidine.

Neurologic

The incidences of adverse reactions associated with the use of local anesthetics may be related to the

total dose of local anesthetic administered and are also dependent upon the particular drug used, the

route of administration and the physical status of the patient. In a prospective review of 10,440 patients

who received lidocaine HCl for spinal anesthesia, the incidences of adverse reactions were reported to

be about 3 percent each for positional headaches, hypotension and backache; 2 percent for shivering;

and less than 1 percent each for peripheral nerve symptoms, nausea, respiratory inadequacy and double

vision. Many of these observations may be related to local anesthetic techniques, with or without a

contribution from the local anesthetic.

In the practice of caudal or lumbar epidural block, occasional unintentional penetration of the

subarachnoid space by the catheter may occur. Subsequent adverse effects may depend partially on the

amount of drug administered subdurally. These may include spinal block of varying magnitude

(including total spinal block), hypotension secondary to spinal block, loss of bladder and bowel control,

and loss of perineal sensation and sexual function. Persistent motor, sensory and/or autonomic

(sphincter control) deficit of some lower spinal segments with slow recovery (several months) or

incomplete recovery have been reported in rare instances when caudal or lumbar epidural block has

been attempted. Backache and headache have also been noted following use of these

anesthetic procedures.

There have been reported cases of permanent injury to extraocular muscles requiring surgical repair

following retrobulbar administration.

Hematologic

Methemoglobinemia.

OVERDOSAGE

Acute emergencies from local anesthetics are generally related to high plasma levels encountered

during therapeutic use of local anesthetics or to unintended subarachnoid injection of local anesthetic

solution (see ADVERSE REACTIONS, WARNINGS, and PRECAUTIONS).

Management of Local Anesthetic Emergencies

The first consideration is prevention, best accomplished by careful and constant monitoring of

cardiovascular and respiratory vital signs and the patient’s state of consciousness after each local

anesthetic injection. At the first sign of change, oxygen should be administered. The first step in the

management of convulsions, as well as underventilation or apnea due to unintended subarachnoid

injection of drug solution, consists of immediate attention to the maintenance of a patent airway and

assisted or controlled ventilation with oxygen and a delivery system capable of permitting immediate

positive airway pressure by mask. Immediately after the institution of these ventilatory measures, the

adequacy of the circulation should be evaluated, keeping in mind that drugs used to treat convulsions

sometimes depress the circulation when administered intravenously. Should convulsions persist despite

adequate respiratory support, and if the status of the circulation permits, small increments of an ultra-

short acting barbiturate (such as thiopental or thiamylal) or a benzodiazepine (such as diazepam) may be

administered intravenously. The clinician should be familiar, prior to the use of local anesthetics, with

these anticonvulsant drugs. Supportive treatment of circulatory depression may require administration

of intravenous fluids and, when appropriate, a vasopressor as directed by the clinical situation (e.g.,

ephedrine).

If not treated immediately, both convulsions and cardiovascular depression can result in hypoxia,

acidosis, bradycardia, arrhythmias and cardiac arrest. Underventilation or apnea due to unintentional

subarachnoid injection of local anesthetic solution may produce these same signs and also lead to

cardiac arrest if ventilatory support is not instituted. If cardiac arrest should occur, standard

cardiopulmonary resuscitative measures should be instituted.

Endotracheal intubation, employing drugs and techniques familiar to the clinician, may be indicated, after

initial administration of oxygen by mask, if difficulty is encountered in the maintenance of a patent

airway or if prolonged ventilatory support (assisted or controlled) is indicated.

Dialysis is of negligible value in the treatment of acute overdosage with lidocaine HCl.

The oral LD

of lidocaine HCl in non-fasted female rats is 459 (346 to 773) mg/kg (as the salt) and 214

(159 to 324) mg/kg (as the salt) in fasted female rats.

DOSAGE AND ADMINISTRATION

Table 1 (Recommended Dosages) summarizes the recommended volumes and concentrations of

Xylocaine Injection for various types of anesthetic procedures. The dosages suggested in this table

are for normal healthy adults and refer to the use of epinephrine-free solutions. When larger volumes

are required, only solutions containing epinephrine should be used except in those cases where

vasopressor drugs may be contraindicated.

There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of

local anesthetics following arthroscopic and other surgical procedures. Xylocaine is not approved for

this use (see WARNINGS and DOSAGE AND ADMINISTRATION).

These recommended doses serve only as a guide to the amount of anesthetic required for most routine

procedures. The actual volumes and concentrations to be used depend on a number of factors such as

type and extent of surgical procedure, depth of anesthesia and degree of muscular relaxation required,

duration of anesthesia required, and the physical condition of the patient. In all cases the lowest

concentration and smallest dose that will produce the desired result should be given. Dosages should

be reduced for children and for the elderly and debilitated patients and patients with cardiac and/or liver

disease.

The onset of anesthesia, the duration of anesthesia and the degree of muscular relaxation are

proportional to the volume and concentration (i.e., total dose) of local anesthetic used. Thus, an

increase in volume and concentration of Xylocaine Injection will decrease the onset of anesthesia,

prolong the duration of anesthesia, provide a greater degree of muscular relaxation and increase the

segmental spread of anesthesia. However, increasing the volume and concentration of Xylocaine

Injection may result in a more profound fall in blood pressure when used in epidural anesthesia.

Although the incidence of side effects with lidocaine HCl is quite low, caution should be exercised

when employing large volumes and concentrations, since the incidence of side effects is directly

proportional to the total dose of local anesthetic agent injected.

For intravenous regional anesthesia, only the 50 mL single dose vial containing Xylocaine (lidocaine

HCl) 0.5% Injection should be used.

Epidural Anesthesia

For epidural anesthesia, only the following dosage forms Xylocaine Injection are recommended:

1% without epinephrine

10 mL Plastic Ampule

1% without epinephrine

30 mL single dose solutions

1% with epinephrine 1:200,000

30 mL single dose solutions

1.5% without epinephrine

10 mL Plastic Ampule

1.5% without epinephrine

20 mL Plastic Ampule

1.5% with epinephrine

1:200,000

30 mL ampules, 30 mL single dose

solutions

2% without epinephrine

10 mL Plastic Ampule

2% with epinephrine 1:200,000

20 mL ampules, 20 mL single dose

solutions

Although these solutions are intended specifically for epidural anesthesia, they may also be used for

infiltration and peripheral nerve block, provided they are employed as single dose units. These

solutions contain no bacteriostatic agent.

In epidural anesthesia, the dosage varies with the numb r of dermatomes to be anesthetized (generally 2

to 3 mL of the indicated concentration per dermatome).

Caudal and Lumbar Epidural Block

As a precaution against the adverse experience sometimes observed following unintentional penetration

of the subarachnoid space, a test dose such as 2 to 3 mL of 1.5% lidocaine HCl should be administered

at least 5 minutes prior to injecting the total volume required for a lumbar or caudal epidural block. The

test dose should be repeated if the patient is moved in a manner that may have displaced the catheter.

Epinephrine, if contained in the test dose (10 to 15 mcg have been suggested), may serve as a warning of

unintentional intravascular injection. If injected into a blood vessel, this amount of epinephrine is likely

to produce a transient “epinephrine response” within 45 seconds, consisting of an increase in heart rate

and systolic blood pressure, circumoral pallor, palpitations and nervousness in the unsedated patient.

The sedated patient may exhibit only a pulse rate increase of 20 or more beats per minute for 15 or

more seconds. Patients on beta blockers may not manifest changes in heart rate, but blood pressure

monitoring can detect an evanescent rise in systolic blood pressure. Adequate time should be allowed

for onset of anesthesia after administration of each test dose. The rapid injection of a large volume of

Xylocaine Injection through the catheter should be avoided, and, when feasible, fractional doses should

be administered.

In the event of the known injection of a large volume of local anesthetic solution into the subarachnoid

space, after suitable resuscitation and if the catheter is in place, consider attempting the recovery of

drug by draining a moderate amount of cerebrospinal fluid (such as 10 mL) through the epidural

catheter.

MAXIMUM RECOMMENDED DOSAGES

Adults

For normal healthy adults, the individual maximum recommended dose of lidocaine HCl with

epinephrine should not exceed 7 mg/kg (3.5 mg/lb) of body weight, and in general it is recommended

that the maximum total dose not exceed 500 mg. When used without epinephrine the maximum individual

dose should not exceed 4.5 mg/kg (2 mg/lb) of body weight, and in general it is recommended that the

maximum total dose does not exceed 300 mg. For continuous epidural or caudal anesthesia, the

maximum recommended dosage should not be administered at intervals of less than 90 minutes. When

continuous lumbar or caudal epidural anesthesia is used for non-obstetrical procedures, more drug may

be administered if required to produce adequate anesthesia.

The maximum recommended dose per 90 minute period of lidocaine hydrochloride for paracervical

block in obstetrical patients and non-obstetrical patients is 200 mg total. One half of the total dose is

usually administered to each side. Inject slowly, five minutes between sides (see also discussion of

paracervical block in PRECAUTIONS).

For intravenous regional anesthesia, the dose administered should not exceed 4 mg/kg in adults.

Children

It is difficult to recommend a maximum dose of any drug for children, since this varies as a function of

age and weight. For children over 3 years of age who have a normal lean body mass and normal body

development, the maximum dose is determined by the child’s age and weight. For example, in a child of

5 years weighing 50 lbs the dose of lidocaine HCl should not exceed 75 to 100 mg (1.5 to 2 mg/lb).

The use of even more dilute solutions (i.e., 0.25 to 0.5%) and total dosages not to exceed 3 mg/kg (1.4

mg/lb) are recommended for induction of intravenous regional anesthesia in children.

In order to guard against systemic toxicity, the lowest effective concentration and lowest effective dose

should be used at all times. In some cases it will be necessary to dilute available concentrations with

0.9% sodium chloride injection in order to obtain the required final concentration.

NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration

prior to administration whenever the solution and container permit. The Injection is not to be used if its

color is pinkish or darker than slightly yellow or if it contains a precipitate.

Table 1: Recommended Dosages

Procedure

Xylocaine (lidocaine hydrochloride)

Injection (without epinephrine)

Conc (%)

Vol (mL)

Total Dose (mg)

Infiltration

Percutaneous

0.5 or 1

1 to 60

5 to 300

Intravenous regional

10 to 60

50 to 300

Peripheral Nerve Blocks, e.g.,

Brachial

15 to 20

225 to 300

Dental

1 to 5

20 to 100

Intercostal

Paravertebral

3 to 5

30 to 50

Pundendal (each side)

Paracervical

Obstetrical analgesia (each side)

Sympathetic Nerve Blocks, e.g.,

Cervical (stellate ganglion)

Lumbar

5 to 10

50 to 100

Central Neural Blocks

Epidural *

Thoracic

20 to 30

200 to 300

Lumbar

Analgesia

25 to 30

250 to 300

Anesthesia

15 to 20

225 to 300

10 to 15

200 to 300

Caudal

Obstetrical analgesia

20 to 30

200 to 300

Surgical anesthesia

15 to 20

225 to 300

* Dose determined by number of dermatomes to be anesthetized (2 to 3 mL/dermatome).

THE ABOVE SUGGESTED CONCENTRATIONS AND VOLUMES SERVE ONLY AS A

GUIDE.OTHER VOLUMES AND CONCENTRATIONS MAY BE USED PROVIDED THE TOTAL

MAXIMUM RECOMMENDED DOSE IS NOT EXCEEDED.

STERILIZATION, STORAGE AND TECHNICAL PROCEDURES

Disinfecting agents containing heavy metals, which cause release of respective ions (mercury, zinc,

copper, etc) should not be used for skin or mucous membrane disinfection as they have been related to

incidents of swelling and edema. When chemical disinfection of multi-dose vials is desired, either

isopropyl alcohol (91%) or ethyl alcohol (70%) is recommended. Many commercially available brands

of rubbing alcohol, as well as solutions of ethyl alcohol not of USP grade, contain denaturants which

are injurious to rubber and therefore are not to be used.

Dosage forms listed as Xylocaine-MPF indicate single dose solutions that are Methyl Paraben Free

(MPF).

HOW SUPPLIED

Xylocaine

(lidocaine HCl Injection, USP)

Product Code

Unit of Sale

Strength

Each

480457

NDC 63323-484-57

Unit of 25

0.5%

(250 mg per 50 mL)

(5 mg per mL)

NDC 63323-484-57

50 mL Multiple Dose Vial

480527

NDC 63323-485-27

Unit of 25

(200 mg per 20 mL)

(10 mg per mL)

NDC 63323-485-01

20 mL Multiple Dose Vial

480557

NDC 63323-485-57

Unit of 25

(500 mg per 50 mL)

NDC 63323-485-03

50 mL Multiple Dose Vial

(10 mg per mL)

480617

NDC 63323-486-17

Unit of 25

(200 mg per 10 mL)

(20 mg per mL)

NDC 63323-486-01

10 mL Multiple Dose Vial

480627

NDC 63323-486-27

Unit of 25

(400 mg per 20 mL)

(20 mg per mL)

NDC 63323-486-02

20 mL Multiple Dose Vial

480657

NDC 63323-486-57

Unit of 25

(1,000 mg per 50 mL)

(20 mg per mL)

NDC 63323-486-05

50 mL Multiple Dose Vial

Xylocaine

-MPF (lidocaine HCl Injection, USP)

Product Code

Unit of Sale

Strength

Each

491157

NDC 63323-491-57

Unit of 25

0.5%

(250 mg per 50 mL)

(5 mg per mL)

NDC 63323-491-01

50 mL Single Dose Vial

491227

NDC 63323-492-27

Unit of 25

(20 mg per 2 mL)

(10 mg per mL)

NDC 63323-492-04

2 mL Single Dose Vial

491257

NDC 63323-492-57

Unit of 25

(50 mg per 5 mL)

(10 mg per mL)

NDC 63323-492-09

5 mL Single Dose Vial

491297

NDC 63323-492-97

Unit of 5

(100 mg per 10 mL)

(10 mg per mL)

NDC 63323-492-08

10 mL Plastic Ampule

491237

NDC 63323-492-37

Unit of 25

(300 mg per 30 mL)

(10 mg per mL)

NDC 63323-492-07

30 mL Single Dose Vial

491231

NDC 63323-492-31

Unit of 5

(300 mg per 30 mL)

(10 mg per mL)

NDC 63323-492-03

30 mL Single Dose Vial

491397

NDC 63323-493-97

Unit of 5

1.5%

(150 mg per 10 mL)

(15 mg per mL)

NDC 63323-493-03

10 mL Plastic Ampule

491391

NDC 63323-493-91

Unit of 5

1.5%

(300 mg per 20 mL)

(15 mg per mL)

NDC 63323-493-01

20 mL Plastic Ampule

491527

NDC 63323-495-27

Unit of 25

(40 mg per 2 mL)

(20 mg per mL)

NDC 63323-495-09

2 mL Single Dose Vial

491507

NDC 63323-495-07

NDC 63323-495-04

Unit of 25

(100 mg per 5 mL)

(20 mg per mL)

5 mL Single Dose Vial

491697

NDC 63323-496-97

Unit of 5

(200 mg per 10 mL)

(20 mg per mL)

NDC 63323-496-03

10 mL Plastic Ampule

Xylocaine

(lidocaine HCl and epinephrine Injection, USP) with Epinephrine 1:100,000

Product Code

Unit of Sale

Strength

Each

480217

NDC 63323-482-17

Unit of 25

(100 mg per 10 mL)

(10 mg per mL)

NDC 63323-482-01

10 mL Multiple Dose Vial

480227

NDC 63323-482-27

Unit of 25

(200 mg per 20 mL)

(10 mg per mL)

NDC 63323-482-03

20 mL Multiple Dose Vial

480257

NDC 63323-482-57

Unit of 25

(500 mg per 50 mL)

(10 mg per mL)

NDC 63323-482-05

50 mL Multiple Dose Vial

480327

NDC 63323-483-27

Unit of 25

(400 mg per 20 mL)

(20 mg per mL)

NDC 63323-483-03

20 mL Multiple Dose Vial

480357

NDC 63323-483-57

Unit of 25

(1,000 mg per 5 mL)

(20 mg per mL)

NDC 63323-483-01

50 mL Multiple Dose Vial

Xylocaine

(lidocaine HCl and epinephrine Injection, USP) with Epinephrine 1:200,000

Product Code

Unit of Sale

Strength

Each

480157

NDC 63323-481-57

Unit of 25

0.5%

(250 mg per 50 mL)

(5 mg per mL)

NDC 63323-481-01

50 mL Multiple Dose Vial

Xylocaine

-MPF (lidocaine HCl and epinephrine Injection, USP) with Epinephrine 1:200,000

Product Code

Unit of Sale

Strength

Each

480717

NDC 63323-487-17

Unit of 25

(100 mg per 10 mL)

(10 mg per mL)

NDC 63323-487-01

10 mL Single Dose Vial

480737

NDC 63323-487-37

Unit of 25

(300 mg per 30 mL)

(10 mg per mL)

NDC 63323-487-07

30 mL Single Dose Vial

480731

NDC 63323-487-31

Unit of 5

(300 mg per 30 mL)

(10 mg per mL)

NDC 63323-487-03

30 mL Single Dose Vial

480817

NDC 63323-488-17

1.5%

NDC 63323-488-01

Unit of 25

(150 mg per 10 mL)

(15 mg per mL)

10 mL Single Dose Vial

480837

NDC 63323-488-37

Unit of 25

1.5%

(450 mg per 30 mL)

(15 mg per mL)

NDC 63323-488-07

30 mL Single Dose Vial

480831

NDC 63323-488-31

Unit of 5

1.5%

(450 mg per 30 mL)

(15 mg per mL)

NDC 63323-488-03

30 mL Single Dose Vial

480917

NDC 63323-489-17

Unit of 25

(200 mg per 10 mL)

(20 mg per mL)

NDC 63323-489-01

10 mL Single Dose Vial

480927

NDC 63323-489-27

Unit of 25

(400 mg per 20 mL)

(20 mg per mL)

NDC 63323-489-02

20 mL Single Dose Vial

480921

NDC 63323-489-21

Unit of 5

(400 mg per 20 mL)

(20 mg per mL)

NDC 63323-489-03

20 mL Single Dose Vial

For single-dose vials and ampules: Discard unused portion.

All solutions should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Protect from light.

All trademarks are the property of Fresenius Kabi USA, LLC.

Fresenius Kabi Log o

www.fresenius-kabi.com/us

4 5 1 1 7 5 F

Revised: March 2019

SODIUM CHLORIDE - sodium chloride injection

Sodium Chloride Injection, USP

0.9%

Fresenius Kabi USA, LLC

DESCRIPTION

Sodium Chloride Injection, USP, 0.9% is a sterile, nonpyrogenic solution. The osmolarity is 300

mOsmol per liter (calculated).

Each mL contains: Sodium chloride 9 mg; Water for Injection q.s. It contains no bacteriostat,

antimicrobial agent or added buffer and is supplied only in single dose containers. Hydrochloric acid

and/or sodium hydroxide may have been added for pH adjustment (pH 4.5-7.0).

Sodium chloride occurs as colorless cubic crystals or white crystalline powder and has a saline taste.

Sodium chloride is freely soluble in water. It is soluble in glycerin and slightly soluble in alcohol.

The empirical formula for sodium chloride is NaCl and the molecular weight is 58.44.

CLINICAL PHARMACOLOGY

Sodium chloride in water dissociates to provide sodium (Na +) and chloride (Cl —) ions. These ions

are normal constituents of the body fluids (principally extracellular) and are essential for maintaining

electrolyte balance.

The distribution and excretion of sodium (Na +) and chloride (Cl —) are largely under the control of the

kidney which maintains a balance between intake and output.

The small volume of fluid and amount of sodium chloride provided by Sodium Chloride Injection, USP,

0.9%, when used only as a vehicle for parenteral injection of drugs, is unlikely to exert a significant

effect on fluid and electrolyte balance except possibly in very small infants.

Water is an essential constituent of all body tissues and accounts for approximately 70% of total body

weight. Average normal adult daily requirement ranges from two to three liters (1 to 1.5 liters each for

insensible water loss by perspiration and urine production).

Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on

the concentration of electrolytes in the body compartments and sodium (Na +) plays a major role in

maintaining physiologic equilibrium.

INDICATIONS AND USAGE

Sodium Chloride Injection, USP, 0.9% preparations are indicated for diluting or dissolving drugs for

intramuscular, intravenous or subcutaneous injection according to instructions of the manufacturer of the

drug to be administered.

Sodium Chloride Injection, USP, 0.9% is also indicated for use in flushing of intravenous catheters.

WARNINGS

For use in newborns, when a sodium chloride solution is required for preparation or diluting

medications or in flushing intravenous catheters, only preservative free Sodium Chloride Injection,

USP, 0.9% should be used.

PRECAUTIONS

General

Consult the manufacturer’s instructions for choice of vehicle, appropriate dilution or volume for

dissolving the drugs to be injected, including the route and rate of injection. Inspect reconstituted

(diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or

discoloration prior to administration.

Pregnancy

Pregnancy Category C—Animal reproduction studies have not been conducted with Sodium Chloride

Injection, USP, 0.9%. It is also not known whether Sodium Chloride Injection can cause fetal harm when

administered to a pregnant woman or can affect reproduction capacity. Sodium Chloride Injection, USP,

0.9% should be given to a pregnant woman only if clearly needed.

ADVERSE REACTIONS

Reactions which may occur because of this solution, added drugs or the technique of reconstitution or

administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the

site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate

countermeasures and, if possible, retrieve and save the remainder of the unused vehicle for examination.

OVERDOSAGE

When used as a diluent, solvent or intravascular flushing solution, this parenteral preparation is unlikely

to pose a threat of sodium chloride or fluid overload except possibly in very small infants. In the event

these should occur, reevaluate the patient and institute appropriate corrective measures. (See

PRECAUTIONS and ADVERSE REACTIONS).

DOSAGE AND ADMINISTRATION

Before Sodium Chloride Injection, USP, 0.9% is used as a vehicle for the administration of a drug,

specific references should be checked for any possible incompatibility with sodium chloride.

The volume of the preparation to be used for diluting or dissolving any drug for injection is dependent

on the vehicle concentration, dose and route of administration as recommended by the manufacturer.

Sodium Chloride Injection, USP, 0.9% is also indicated for use in flushing intravenous catheters. Prior

to and after administration of the medication, the intravenous catheter should be flushed in its entirety

with Sodium Chloride Injection, USP, 0.9%. Use in accord with any warnings or precautions

appropriate to the medication being administered.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to

administration, whenever solution and container permit.

HOW SUPPLIED

Sodium Chloride Injection, USP, 0.9%, preservative free, is available as follows:

Product Code

Unit of Sale

Strength

Each

918602

63323-186-02

Trays of 25

0.9% (18 mg per 2 mL)

(9 mg per ml)

NDC 63323-186-04

2 mL fill, in a 3 mL Single-Dose Vial

918610

63323-186-10

Trays of 25

0.9% (90 mg per 10 mL)

(9 mg per mL)

NDC 63323-186-01

10 mL Single-Dose vial

918620

63323-186

20 Trays of 25

0.9% (180 mg per 20 mL)

(9 mg per mL)

NDC 63323-186-03

20 mL Single-Dose vial

Preservative Free. Discard unused portion.

Use only if solution is clear and seal intact.

Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature].

Fresenius Kabi Log o

www.fresenius-kabi.com/us

45764E

Revised: October 2018

POVIDONE-IODINE

APLICARE POVIDONE-IODINE TRIPLES- povidone-iodine solution

Aplicare Products, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

ACTIVE INGREDIENT

Povidone-iodine USP

PURPOSE

Antiseptic

USE

Antiseptic skin preparation

WARNINGS

Do not use

if allergic to iodine

in the eyes

For external use only

Avoid pooling beneath patient

Avoid excessive heat. Store at room temperature.

Ask a doctor before use if injuries are

deep or puncture wounds

serious burns

Stop use and ask a doctor if

redness, irritations, swelling or pain persists or increases

infection occurs

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or consult a poison control center

immediately.

DIRECTIONS

Apply locally as needed

INACTIVE INGREDIENTS

citric acid,

disodium phosphate,

nonoxynol-9,

sodium hydroxide,

water

OTHER INFORMATION

1% titratable iodine

Not made with natural rubber latex

For hospital or professional use only

Applicator is STERILE if package is intact.

Manufactured by:

Aplicare Products, LLC,

550 Research Parkway

Meriden, CT 06450 USA

Made in USA

For questions or comments:

800-633-5463

Revised: 12/2019

ALCOHOL PREP PAD

ALCOHOL PREP- isopropyl alcohol swab

Dynarex Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

ACTIVE INGREDIENT

Isopropyl Alcohol, 70 % v/v

PURPOSE

Antiseptic

USE

For preparation of the skin prior to injection.

WARNINGS

For external use only

Flammable, keep away from flame or fire

Not for use with electrocautinary devices or procedures

Do not use in eyes

Sterile unless package is damaged or open.

Stop use and ask a doctor if:

Irritation or redness develops

Condition persists for more than 72 hours

Cleansing of an injection site

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or consult a poison control center

immediately.

DIRECTIONS

Wipe injection site vigorously and discard.

INACTIVE INGREDIENTS

Water

OTHER INFORMATION

Store at room temperature: 15 deg C to 30 deg C 59 deg F to 86 deg F

avoid excessive heat

Reorder No. 1113

Made in Chine

Manufactured for:

Dynarex Corporation

Orangeburg, NY 10962

www.dynarex.com

Revised: 11/2019

PRINCIPAL DISPLAY PANEL: P-Care X

NDC 49836-003-18

RX-Only

P-Care X

Kit Contains:

1 Xylocaine

- MPF 1% Single Dose Vial (10 mg/mL) (5mL)

1 Sodium Chloride Injection, USP 0.9% Single Dose Vial (10 mL)

1 Sterile Povidone-Iodine Swabsticks (3 Swabs)

1 Sterile Pair Nitrile Powder-Free Gloves (Size 7.5)

1 Sterile Towel Drape

1 Sterile Fenestrated Towel Drape

2 Sterile Adhesive Bandage

2 Sterile Adhesive Spot Bandage

3 Sterile Packs of 4x4 Gauze (6 Gauzes)

5 Sterile Isopropyl Alcohol 70% Prep Pad

1 Dose

Needles and Syringes Not Included

P-Care x

DISTRIBUTED BY:

SCHMIGS

HAUPPAUGE, NY 11788

NDC 49836-003-18

MANUFACTURED BY:

Rx Pharma Pack

HAUPPAUGE, NY 11788

Questions/Comments 1-844-632-7898

Kit Contents:

Xylocaine

§- MPF 1% (10 mg/mL) (Fresenius Kabi USA, LLC)*

Lidocaine HCl Injection, USP

Sterile, nonpyrogenic, isotonic solution containing sodium chloride and a local anesthetic agent.

Sodium Chloride Injection, USP 0.9% (10 mL) (APP Fresenius Kabi USA, LLC)*

Each mL contains sodium chloride, 9 mg. May contain HCI and/or NaOH for pH adjustment. Sterile,

nonpyrogenic, preservative free.

Sterile Povidone-lodine Swabsticks (Aplicare)*

Sterile Nitrile Powder-Free Gloves (Dynarex) - Size 7.5*

®

Sterile Towel Drape (Dynarex)*

Sterile Fenestrated Towel Drape (Dynarex)*

Sterile Adhesive Bandage (Dynarex)*

Sterile Adhesive Spot Bandage (Dynarex)*

Sterile 4x4 Gauze (Dynarex)*

Sterile Alcohol Prep Pad 70% by Volume (Dynarex)*

§ Xylocaine

(registered trademark of APP Fresenius Kabi, LLC)

* Internal package components remain sterile when stated as long as items are unopened and undamaged.

WARNING: KEEP THIS AND ALL MEDICATION

OUT OF THE REACH OF CHILDREN. IN CASE OF

ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL

ASSISTANCE OR CONTACT A POISON CONTROL

CENTER IMMEDIATELY.

PROTECT FROM LIGHT I AVOID FREEZING

STORE AT CONTROLLED ROOM TEMPERATURE

20º-25ºC (68º-77º F) [SEE USP CONTROLLED

ROOM TEMPERATURE]

DO NOT REFRIGERATE.

Directions for Use: See enclosed inserts.

SUSTAINABLE Certified Sourcing

FORESTRY www.sfiprogram.org

INITIATIVE SFI-01376

ORG 04/2017

This product is not eligible for Medicare or Medicaid reimbursement.

P-Care X

P-CARE X

lidocaine hydrochloride, sodium chloride, povidone-iodine, isopropyl alcohol kit

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:49 8 36 -0 0 3

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:49 8 36 -0 0 3-

1 in 1 PACKAGE, COMBINATION; Type 1: Co nvenience Kit o f Co -

Pa c ka ge

0 6 /16 /20 17

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

1 VIAL, SINGLE-DOSE

5 mL

Pa rt 2

1 VIAL, SINGLE-DOSE

10 mL

Pa rt 3

1 PACKET

6 .5 mL

Pa rt 4

5 POUCH

2.75 mL

Part 1 of 4

XYLOCAINE-MPF

lidocaine hydrochloride injection, solution

Product Information

Route of Administration

EPIDURAL, INFILTRATION, INTRACAUDAL, PERINEURAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

LIDO CAINE HYDRO CHLO RIDE ANHYDRO US (UNII: EC2CNF7XFP)

(LIDOCAINE - UNII:9 8 PI20 0 9 8 7)

LIDOCAINE HYDROCHLORIDE

ANHYDROUS

10 mg

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

7 mg in 1 mL

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

HYDRO CHLO RIC ACID (UNII: QTT1758 2CB)

Packag ing

#

Item

Co de

Package Description

Marketing Start

Date

Marketing End

Date

1

5 mL in 1 VIAL, SINGLE-DOSE; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 0 6 48 8

0 8 /12/20 10

Part 2 of 4

SODIUM CHLORIDE

sodium chloride injection

Product Information

Route of Administration

INTRAVENOUS

Active Ingredient/Active Moiety

Basis of

Ingredient Name

Basis of

Stre ng th

Stre ng th

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X) (SODIUM CATION - UNII:LYR4M0 NH37, CHLORIDE ION -

UNII:Q32ZN48 6 9 8 )

SODIUM

CHLORIDE

9 mg

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

HYDRO CHLO RIC ACID (UNII: QTT1758 2CB)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

Packag ing

#

Item

Co de

Package Description

Marketing Start

Date

Marketing End

Date

1

10 mL in 1 VIAL, SINGLE-DOSE; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 8 8 9 12

0 8 /10 /20 0 0

Part 3 of 4

APLICARE POVIDONE-IODINE TRIPLES

povidone-iodine solution

Product Information

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PO VIDO NE-IO DINE (UNII: 8 5H0 HZU9 9 M) (IODINE - UNII:9 6 79 TC0 7X4)

IODINE

10 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

SO DIUM PHO SPHATE, DIBASIC (UNII: GR6 8 6 LBA74)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

NO NO XYNO L-9 (UNII: 48 Q18 0 SH9 T)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

6 .5 mL in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

RX PHARMA-PACK, INC.

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH NOT FINAL part333A

0 3/0 1/19 9 8

Part 4 of 4

STERILE ALCOHOL PREP PADS

isopropyl alcohol swab

Product Information

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2) (ISOPROPYL ALCOHOL -

UNII:ND2M416 30 2)

ISOPROPYL

ALCOHOL

0 .7 mL in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

0 .55 mL in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH NOT FINAL part333A

0 7/0 1/20 10

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 0 6 48 8

0 6 /16 /20 17

Labeler -

RX PHARMA-PACK, INC. (962149634)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

RX PHARMA-PACK, INC.

9 6 2149 6 34

PACK(49 8 36 -0 0 3)

Revised: 2/2020

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