D-CARE 100X- lidocaine hydrochloride, povidone-iodine, isopropyl alcohol kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987), EPINEPHRINE BITARTRATE (UNII: 30Q7KI53AK) (EPINEPHRINE - UNII:YKH834O4BH)

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. Antiseptic Antiseptic skin preparation Antiseptic For preparation of the skin prior to injection.

Product summary:

Xylocaine® (lidocaine HCl Injection, USP) 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 0.5% (250 mg per 50 mL) (5 mg per mL) Xylocaine® -MPF (lidocaine HCl and epinephrine Injection, USP) with Epinephrine 1:200,000  1% (100 mg per 10 mL) (10 mg per mL) 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

Authorization status:

New Drug Application

Summary of Product characteristics

D-CARE 100X- LIDOCAINE HYDROCHLORIDE, POVIDONE-IODINE, ISOPROPYL
ALCOHOL
RX PHARMA-PACK, INC.
----------
D-CARE 100X
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
H N
• 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.
®
®
14
22
2O
9
13
3
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.
Xyl