4382 FIRST AID KIT- 4382 first aid kit 4381 FIRST AID KIT- 4381 first aid kit 4393 FIRST AID KIT- 4393 first aid kit

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

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Active ingredient:
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)
Available from:
Honeywell Safety Products USA, Inc.
Prescription type:
OTC DRUG
Therapeutic indications:
First aid antibiotic First aid antibiotic First aid antibiotic first aid to help prevent infection in: - minor cuts - scrapes - burns First aid antiseptic Antiseptic cleansing of face, hands, and body without soap and water Eyewash - for flushing the eye to remove loose foreign material, air pollutants or chlorinated water Anti-itch cream - for the temporary relief of itching associated with minor skin irritations and rashes Antiseptic handwash - for hand washing to decrease bacteria on skin - recommended for repeated use 0.9% Sodium Chloride Irrigation USP is not for injection by usual parenteral routes. An electrolyte solution should not be used for irrigation during electrosurgical procedures. First aid antiseptic - first aid to help prevent infection in minor cuts, scrapes, and burns Respiratory stimulant to prevent or treat fainting If swallowed get medical help or contact a Poison Control Center right away.
Product summary:
0.9% Sodium Chloride Irrigation USP is supplied sterile and nonpyrogenic in PIC™ (Plastic Irrigation Container). The 1000 mL and 500 mL containers are packaged 16 per case, the 2000 mL containers are packaged 8 per case, and the 4000 mL containers are packaged 4 per case. 0.9% Sodium Chloride Irrigation USP NDC Cat. No. REF SIZE 0264-2201-00 R5200-01 1000 mL 0264-2201-10 R5201-01 500 mL 0264-2201-50 R5205-01 2000 mL 0264-2201-70 R5207 ,,,,4000 mL Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product. Do not warm above 150°F (66°C).
Authorization status:
unapproved drug other
Authorization number:
0498-0100-02, 0498-0143-04, 0498-0501-00, 0498-0750-36, 0498-3334-00, 0498-4381-01, 0498-4382-01, 0498-4393-01, 59898-420-12

4382 FIRST AID KIT- 4382 first aid

4381 FIRST AID KIT- 4381 first aid

4393 FIRST AID KIT- 4393 first aid

Honeywell Safety Products USA, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been

approved by FDA. For further information about unapproved drugs, click here.

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4381, 4382, 4393 First Aid Kit (ammonia, Triple, NaCl irr, EW, HC cr, BZK wipe, antiseptic

hand gel, alcohol wipe- 145225, Z145225, Z19802)

Triple

Active ingredient

Bacitracin zinc 400 units

Neomycin sulfate (5 mg equivalent to 3.5 mg Neomycin base)

Polymyxin B sulfate 5000 units

Triple

Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Triple

Uses

first aid to help prevent infection in:

minor cuts

scrapes

burns

Triple

Warnings

For external use only

Allergy alert: do not use if you are allergic to any of the ingredients

Do not use

in the eyes

over large areas of the body

Ask a doctor before use if you have

a deep or puncture wounds

animal bites

serious burns

Stop use and ask a doctor if

the condition persists or gets worse

a rash or other allergic reaction develops

you need to use longer than 1 week

Keep out of the reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Triple

Directions

clean the affected area

apply a small amount of the product (an amount equal to the surface area of the tip of a finger) on the

area 1 to 3 times daily

may be covered with a sterile bandage

Triple

Other information

store at 15

to 25

C (59

to 77

tamper evident sealed packets

do not use if packet is torn or opened

Triple

Inactive ingredient

petrolatum

Triple

Questions?

1-800-430-5490

BZK Wipe

Active ingredient

Benzalkonium chloride 0.13% w/v

BZK Wipe

Purpose

First aid antiseptic

BzK Wipe

Uses

Antiseptic cleansing of face, hands, and body without soap and water

BZK Wipe

Warnings

For external use only

Do not use

in the eyes or over large areas of the body

on mucous membranes

on irritated skin

in case of deep puncture wounds, animal bites or serious burns, consult a doctor

longer than 1 week unless directed by a doctor

Stop use and ask a doctor if

if irritation, redness or other symptoms develop

the condition persists or gets worse

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

BZK Wipe

Directions

tear open packet and use as a washcloth

BZK Wipe

Other information

store at room temperature 15

to 30

C (59

- 86

do not reuse towelette

BZK Wipe

Inactive ingredient

water

BZK Wipe

Questions

1-800-430-5490

Eyewash

Active ingredient

Sterile Water 99%

Eyewassh

Purpose

Eyewash

Eyewash

Uses

for flushing the eye to remove loose foreign material, air pollutants or chlorinated water

Eyewash

Warnings

For external use only

Obtain immediate medical treatment for all open wounds in or near eyes.

To avoid contamination, do not touch tip of container to any surface.

Do not reuse.

Once opened, discard.

Do not use

if solution changes color or becomes cloudy

if you have open wounds in or near the eyes, get medical help right away.

Stop use and ask a doctor if

you experience eye pain

changes in vision

continued redness or irritation of the eye

condition worsens or persists

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Eyeash

Directions

remove contacts before using

twist top to remove

flush the affected area as needed

control rate of flow by pressure on the bottle

if necessary, continue flushing with emergency eyewash or shower

Eyewash

Inactive ingredients

sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic

Eyeash

Questions

Call 1-800-430-5490 Honeywell Safety Products USA, Inc. Smithfield, RI 02917

Hydrocortisone

Active ingredient (in each gram)

Hydrocortisone acetate (equivalent to Hydrocortisone 1%)

Hydrcortisone

Purpose

Anti-itch cream

Hydrocortisone

Uses

for the temporary relief of itching associated with minor skin irritations and rashes

Hydrocortisone

Warnings

For external use only

Ask a doctor before use if

you are using any other hydrocortisone product

When using the product

avoid contact with eyes

do not begin use of any other hydrocortisone product unless you have consulted a doctor

do not use for the treatment of diaper rash

Stop use and ask a doctor if

condition worsens

condition persists for more than 7 days

condition clears up and recurs within a few days

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Hydrocortisone

Directions

adults and children 2 years and older:

clean the affected area

apply to the area not more than 3 to 4 times daily

children under 2 years of age: consult a doctor

Hydrocortisone

Other information

store at room temperature (do not freeze)

Hydrocortisone

Inactive ingredients

cetyl alcohol, citric acid, diazolidinyl urea, edetate disodium, glycerin, glyceryl monostearate,

methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, purified water,

stearic acid, trolamine

Hydrocortisone

Questions or Comments?

1-800-430-5490

Hand Sanitizer

Active ingredient

Ethyl alcohol 62%

Hand Sanitizer

Purpose

Antiseptic handwash

Hand Sanitizer

Uses

for hand washing to decrease bacteria on skin

recommended for repeated use

Hand Sanitizer

Warnings

For external use only

Flammable, keep away from fire or flame

When using this product

do not use in the eyes

discontinue use if irritation and redness develops. If condition persists for more than 72 hours

consult a doctor.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Hand Sanitizer

Directions

wet hands thoroughly with product and allow to dry without wiping

Hand Sanitizer

Other information

store at 15

to 25

C (59

to 77

Hand Sanitizer

Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, dl-alpha tocopheryl acetate,

fragrance, PEG-60 almond glycerides, propylene glycol, purified water, triisopropanolamine

Hand Sanitizer

Questions or Comments?

1-800-275-3433 info@waterjel.com www.waterjel.com

Isotonic Solution for Irrigation.

For Irrigation Only.

Not for Injection.

NaCL Irrigant

Des cription

Each 100 mL contains:

Sodium Chloride USP 0.9 g; Water for Injection USP qs

pH adjusted with Hydrochloric Acid NF

pH: 5.0 (4.5–7.0) Calculated Osmolarity: 310 mOsmol/liter

Concentration of Electrolytes (mEq/liter): Sodium 154; Chloride 154

0.9% Sodium Chloride Irrigation USP is sterile, nonpyrogenic, isotonic and contains no bacteriostatic

or antimicrobial agents.

The formula of the active ingredient is:

Ingredient Molecular Formula Molecular Weight

Sodium Chloride USP NaCl 58.44

The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral

drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic

container is also virtually impermeable to vapor transmission and, therefore, requires no overwrap to

maintain the proper drug concentration. The safety of the plastic container has been confirmed by

biological evaluation procedures. The material passes Class Vl testing as specified in the U.S.

Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is

nontoxic and biologically inert.

The PIC™ Container is PVC-free and DEHP-free.

Ingredient Molecular Formula Molecular Weight

Sodium Chloride USP NaCl 58.44

The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral

drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic

container is also virtually impermeable to vapor transmission and, therefore, requires no overwrap to

maintain the proper drug concentration. The safety of the plastic container has been confirmed by

biological evaluation procedures. The material passes Class Vl testing as specified in the U.S.

Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is

nontoxic and biologically inert.

The PIC™ Container is PVC-free and DEHP-free.

NaCL Irrigant

Clinical Pharmacology

0.9% Sodium Chloride Irrigation USP is utilized for a variety of clinical indications such as sterile

irrigation of body cavities, tissues or wounds, indwelling urethral catheters, surgical drainage tubes,

and for washing, rinsing or soaking surgical dressings, instruments and laboratory specimens. It also

serves as a diluent or vehicle for drugs used for irrigation or other pharmaceutical preparations.

0.9% Sodium Chloride Irrigation USP provides an isotonic saline irrigation identical in composition

with 0.9% Sodium Chloride Injection USP (normal saline).

Physiological irrigation solutions are considered generally compatible with living tissues and organs.

Sodium, the major cation of the extracellular fluid, functions primarily in the control of water

distribution, fluid balance, and osmotic pressure of body fluids. Sodium is also associated with

chloride and bicarbonate in the regulation of the acid-base equilibrium of body fluid.

Chloride, the major extracellular anion, closely follows the metabolism of sodium, and changes in the

acid-base balance of the body are reflected by changes in the chloride concentration.

Indication and Usage

NaCl Irrigant

0.9% Sodium Chloride Irrigation USP is indicated for all general irrigation, washing, rinsing and

dilution purposes which permit use of a sterile, nonpyrogenic electrolyte solution.

NaCl Irrigant

Contraindications

0.9% Sodium Chloride Irrigation USP is not for injection by usual parenteral routes.

An electrolyte solution should not be used for irrigation during electrosurgical procedures.

Warnings

NaCl Irrigant

FOR IRRIGATION ONLY. NOT FOR INJECTION.

Irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes;

thus, irrigation solutions must be regarded as systemic drugs. Absorption of large amounts can cause

fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration,

congested states or pulmonary edema.

The risk of dilutional states is inversely proportional to the electrolyte concentrations of the

administered parenteral solutions. The risk of solute overload causing congested states with peripheral

and pulmonary edema is directly proportional to the electrolyte concentration.

Do not warm above 150°F (66°C).

After opening container, its contents should be used promptly to minimize the possibility of bacterial

growth or pyrogen formation.

Discard unused portion of irrigating solution since it contains no preservatives.

Precautions

NaCl Irrigant

General

Use aseptic technique when preparing and administering sterile irrigation solutions.

Use only if solution is clear and container and seal are intact.

Do not use for irrigation that may result in absorption of large amounts of fluid into the blood.

Caution should be observed when the solution is used for continuous irrigation or allowed to "dwell"

inside body cavities because of possible absorption into the blood stream and the production of

circulatory overload.

When used for irrigation via appropriate irrigation equipment, the administration set should be attached

promptly. Unused portions should be discarded and a fresh container of appropriate size used for the

start up of each cycle or repeat procedure. For repeated irrigations of urethral catheters, a separate

container should be used for each patient.

Laboratory Tests

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid

balance, electrolyte concentrations, and acid-base balance after prolonged irrigation, when fluid

absorption is suspected, or whenever the condition of the patient warrants such evaluation.

Drug Interactions

Some additives may be incompatible. Consult with pharmacist.When introducing additives, use aseptic

technique.Mix thoroughly.

Do not store.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies with 0.9% Sodium Chloride Irrigation USP have not been performed to evaluate carcinogenic

potential, mutagenic potential, or effects on fertility.

Pregnancy

Teratogenic Effects

Animal reproduction studies have not been conducted with 0.9% Sodium Chloride Irrigation USP. It is

also not known whether 0.9% Sodium Chloride Irrigation USP can cause fetal harm when administered

to a pregnant woman or can affect reproduction capacity. 0.9% Sodium Chloride Irrigation USP should

be given to a pregnant woman only if clearly needed.

Labor and Delivery

Safety and effectiveness of 0.9% Sodium Chloride Irrigation USP during labor and delivery have not

been established. Caution should be exercised, and the fluid balance, glucose and electrolyte

concentrations, and acid-base balance, of both mother and fetus should be evaluated periodically or

whenever warranted by the condition of the patient or fetus.

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 0.9% Sodium Chloride Irrigation USP is administered to a

nursing woman.

Pediatric Use

The safety and effectiveness of 0.9% Sodium Chloride Irrigation USP in pediatric patients have not

been established. Its limited use in pediatric patients has been inadequate to fully define proper dosage

and limitations for use.

Geriatric Use

Clinical studies of 0.9% Sodium Chloride Irrigation USP did not include a sufficient number of patients

age 65 years and over to determine whether they respond differently from younger subjects. In general,

dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing

range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of

concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug

may be greater in patients with impaired renal function.Because elderly patients are more likely to have

decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal

function.Frequent laboratory determinations and clinical evaluations are recommended to monitor

changes in blood glucose, electrolyte concentrations, and renal function.

Adverse Reactions

Possible adverse effects arising from the irrigation of body cavities, tissues, or indwelling catheters

and tubes can be minimized when proper procedures are followed. Displaced catheters or drainage

tubes can lead to irrigation or infiltration of unintended structures or cavities. Excessive volume or

pressure during irrigation of closed cavities may cause undue distension or disruption of tissues.

Accidental contamination from careless technique may transmit infection.

If an adverse reaction does occur, discontinue administration of the irrigant, evaluate the patient,

institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if

deemed necessary.

Overdos age

In the event of overhydration or solute overload, reevaluate the patient's condition, and institute

appropriate corrective treatment. Intravasular volume overload may respond to hemodialysis. See

WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS.

Dosage and Administration

As required for irrigation.

When used as a diluent, or vehicle for other drugs, the drug manufacturer's recommendations should be

followed.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic

techniques. Mix thoroughly. Do not store.

Solutions should be inspected visually for particulate matter and discoloration prior to administration,

whenever solution and container permits.

How Supplied

0.9% Sodium Chloride Irrigation USP is supplied sterile and nonpyrogenic in PIC™ (Plastic Irrigation

Container). The 1000 mL and 500 mL containers are packaged 16 per case, the 2000 mL containers are

packaged 8 per case, and the 4000 mL containers are packaged 4 per case.

0.9% Sodium Chloride Irrigation USP

NDC Cat. No. REF SIZE

0264-2201-00 R5200-01 1000 mL

0264-2201-10 R5201-01 500 mL

0264-2201-50 R5205-01 2000 mL

0264-2201-70 R5207 ,,,,4000 mL

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from

freezing. It is recommended that the product be stored at room temperature (25°C); however, brief

exposure up to 40°C does not adversely affect the product.

Do not warm above 150°F (66°C).

SPL Unclassified Section

Rx only

Revised: March 2009

PIC is a trademark of B. Braun Medical Inc.

DIRECTIONS FOR USE OF PIC™ (PLASTIC IRRIGATION CONTAINER)

Not for injection.

Aseptic technique is required.

Caution – Before use, perform the following checks:

(a) Read the label. Ensure solution is the one ordered and is within the expiration date.

(b) Invert container and inspect the solution in good light for cloudiness, haze, or particulate matter;

check the

container for leakage or damage. Any container which is suspect should not be used.

Use only if solution is clear and container and seal are intact

Single unit container. Discard unused portion.

Outer Closure Removal – Grasp the container with one hand and turn the breakaway ring

counterclockwise with the other hand until slight resistance is felt. Then, twisting the container in the

opposite direction, turn the breakaway ring sharply until the entire outer cap is loose and can be lifted

off.

Figure 1

Connect the administration set through the sterile set port according to set instructions or remove screw

cap and pour.

[Fig 2]

Figure 2

Do not warm above 150°F (66°C) to assure minimal bottle distortion. Keep bottles upright.

SPL Unclassified Section

B. Braun Medical Inc.

Irvine, CA 92614-5895 USA

Made in USA

Y36-002-699

Alcohol Wipe

Active ingredient

Isopropyl alcohol 70%

Alcohol Wipe

Purpose

First aid antiseptic

Alcohol Wipe

Uses

first aid to help prevent infection in minor cuts, scrapes, and burns

Alcohol Wipe

Warnings

For external use only

Flammable, keep away from fire and flame

Do not use

in or near eyes

over large areas of the body

Ask a doctor before use if you have

deep or puncture wounds

animal bites

serious burns

When using this product

do not use longer than 1 week unless directed by a doctor

Stop use and consult a doctor if

condition persists or gets worse

Keep out of the reach of children

If swallowed, get medical help or contact a Poison Control center right away

Alcohol Wipe

Directions

clean the affected area

may be covered with a sterile bandage

apply wipe to affeted are 1 to 3 times daily

discard wipe after single use

Alcohol Wipe

Other information

store at room temperature 15

to 25

C (59

to 77

do not use if packet is torn or opened

Alcohol Wipe

Inactive ingredient

water

Alcohol Wipe

Questions

1-800-430-5490

Ammonia Inhalent

Active ingredient

Ammonia 15%

Ammonioa Inhalent

Purpose

Respiratory stimulant

Ammonia Inhalent

Uses

to prevent or treat fainting

Keep out of reach of children

If swallowed get medical help or contact a Poison Control Center right away.

Ammonia Inhalent

Warnings

For external use only

Do not use

if you have breathing problems such as asthma or emphysema

Stop use and ask a doctor if

condition persists

Ammonia Inhalent

Directions

hold inhalant away from face and crush ampoule between thumb and forefinger at position indicated

on sleeve.

hold near nostrils for inhalation of volatile vapor

Ammonia Inhalent

Other information

store at room temperature away from light

Ammonia Inhalent

Inactive ingredients

alcohol USP, FD&C red #40, lavender oil, lemon oil fcc, nutmeg oil, purified water at room

temperature away from light

Ammonia Inhalent

Questions or Comments?

1-800-430-5490

4381

145225 Kit Contents

1 AMMONIA INHALANTS 10 PER

1 EYE DRESS PKT W/4 ADH STRIPS

1 ADHESIVE TAPE W/P 1" X 10YDS

1 ADH BDG, CLOTH, 1"X3", 16 PER

1 FIRST AID GUIDE ASHI

1 EMERGENCY SURVIVAL BLANKET

2 ELASTIC ROLLED GZ 3" ST

2 ELASTIC ROLLED GZ 4" ST

2 BLOODSTOPPER

8 ABD COMBINE PAD 5" X 9"

1 GZE PADS STERILE 3"X 3" 10'S

1 GZE PADS STERILE 4"X 4" 10'S

6 ABD PADS 8"X10" STERILE

4 MULTI-TRAUMA DRESSING 12"X30"

2 MEDI-RIP BANDAGE 6"X5YDS EA

6 ELASTIC BANDAGE 3" X 4.5YD

4 ELASTIC BANDAGE 6" X 4.5 YD

1 CPR FILTERSHIELD 77-100

1 FLASHLIGHT STD

1 RADIO AM FREQ BATTERY POWERED

1 WATER JEL FACIAL DRS 12X16 EA

1 TRIPLE BIOTIC .5 GRAM PKT 20

1 SOD. CHLORIDE 0.9% 500ML EA

2 INSTA-GLUCOSE 31 GRAMS

1 4OZ BFS EYEWASH TRILINGUAL BOTTLE

1 SPHYG ANEROID(NO PIN) ADULT

1 STETHESCOPE NURSES VARIOUS COLORS

1 PENLIGHT DISPOSABLE EACH

1 FORCEPS WITH MAGNIFIER

1 SCISSOR UTILITY SHEARS 7-1/4"

1 SCISSOR LISTER BDG S/S 5 1/2"

2 BATTERY - RAYOVAC SIZE AA

2 BATTERY - SIZE D

1 TONGUE BLADES SR. WRAPPED 12'S

1 SAFETY PINS LARGE #3 DOZ

6 SPLINT-CARDBOARD HAND & WRIST

4 SPLINT BOARD W/PAD SML 12"X6"

1 LBL STOCK 6-3/8"X4"

1 LBL STOCK 4"X2-7/8"

1 LBL STOCK 3"x1-7/8"

1 10 PR NITRILE GLVES ZIP BAG

4 EMER.YELLOW BLKT 54"X80" POLYP

1 ANTISEPTIC HAND GEL 4OZ

1 ANTISEPTIC WIPES 20'S ZIP LOCK

1 HYDROCORTISONE 20'S ZIP LOCK

1 ALCOHOL WIPES 50'S ZIP LOCK

1 BAG FOR DELUXE TRAUMA KIT

4 COLD PACK 5"X 9" BULK

2 TRI BNDG NON WOVEN 40"X40"X56"

1 WOVEN KNUCKLE 8'S

1 FINGERTIP "T" 8/BX

4382

Z145225 Kit Contents

1 AMMONIA INHALANTS 10 PER

1 EYE DRESS PKT W/4 ADH STRIPS

1 ADHESIVE TAPE W/P 1" X 10YDS

1 ADH BDG, CLOTH, 1"X3", 16 PER

1 FIRST AID GUIDE ASHI

1 EMERGENCY SURVIVAL BLANKET

2 ELASTIC ROLLED GZ 3" ST

2 ELASTIC ROLLED GZ 4" ST

2 BLOODSTOPPER

8 ABD COMBINE PAD 5" X 9"

1 GZE PADS STERILE 3"X 3" 10'S

1 GZE PADS STERILE 4"X 4" 10'S

6 ABD PADS 8"X10" STERILE

4 MULTI-TRAUMA DRESSING 12"X30"

2 MEDI-RIP BANDAGE 6"X5YDS EA

6 ELASTIC BANDAGE 3" X 4.5YD

4 ELASTIC BANDAGE 6" X 4.5 YD

1 CPR FILTERSHIELD 77-100

1 FLASHLIGHT STD

1 RADIO AM FREQ BATTERY POWERED

1 WATER JEL FACIAL DRS 12X16 EA

1 TRIPLE BIOTIC .5 GRAM PKT 20

1 SOD. CHLORIDE 0.9% 500ML EA

2 INSTA-GLUCOSE 31 GRAMS

1 4OZ BFS EYEWASH TRILINGUAL BOTTLE

1 SPHYG ANEROID(NO PIN) ADULT

1 STETHESCOPE NURSES VARIOUS COLORS

1 PENLIGHT DISPOSABLE EACH

1 FORCEPS WITH MAGNIFIER

1 SCISSOR UTILITY SHEARS 7-1/4"

1 SCISSOR LISTER BDG S/S 5 1/2"

2 BATTERY - RAYOVAC SIZE AA

2 BATTERY - SIZE D

1 TONGUE BLADES SR. WRAPPED 12'S

1 SAFETY PINS LARGE #3 DOZ

6 SPLINT-CARDBOARD HAND & WRIST

4 SPLINT BOARD W/PAD SML 12"X6"

1 LBL STOCK 6-3/8"X4"

1 LBL STOCK 4"X2-7/8"

1 LBL STOCK 3"x1-7/8"

1 10 PR NITRILE GLVES ZIP BAG

4 EMER.YELLOW BLKT 54"X80" POLYP

1 ANTISEPTIC HAND GEL 4OZ

1 ANTISEPTIC WIPES 20'S ZIP LOCK

1 HYDROCORTISONE 20'S ZIP LOCK

1 ALCOHOL WIPES 50'S ZIP LOCK

1 BAG FOR DELUXE TRAUMA KIT

4 COLD PACK 5"X 9" BULK

2 TRI BNDG NON WOVEN 40"X40"X56"

1 WOVEN KNUCKLE 8'S

1 FINGERTIP "T" 8/BX

4393

Z19802 kit contents

1 AMMONIA INHALANTS 10 PER

1 EYE DRESS PKT W/4 ADH STRIPS

1 ADHESIVE TAPE W/P 1" X 10YDS

1 ADH BDG, CLOTH, 1"X3", 16 PER

1 FIRST AID GUIDE ASHI

1 EMERGENCY SURVIVAL BLANKET

2 ELASTIC ROLLED GZ 3" ST

2 ELASTIC ROLLED GZ 4" ST

2 BLOODSTOPPER

8 ABD COMBINE PAD 5" X 9"

1 GZE PADS STERILE 3"X 3" 10'S

1 GZE PADS STERILE 4"X 4" 10'S

6 ABD PADS 8"X10" STERILE

4 MULTI-TRAUMA DRESSING 12"X30"

2 MEDI-RIP BANDAGE 6"X5YDS EA

6 ELASTIC BANDAGE 3" X 4.5YD

4 ELASTIC BANDAGE 6" X 4.5 YD

1 CPR FILTERSHIELD 77-100

1 FLASHLIGHT STD

1 RADIO AM FREQ BATTERY POWERED

1 WATER JEL FACIAL DRS 12X16 EA

1 TRIPLE BIOTIC .5 GRAM PKT 20

1 SOD. CHLORIDE 0.9% 500ML EA

2 INSTA-GLUCOSE 31 GRAMS

1 4OZ BFS EYEWASH TRILINGUAL BOTTLE

1 SPHYG ANEROID(NO PIN) ADULT

1 STETHESCOPE NURSES VARIOUS COLORS

1 PENLIGHT DISPOSABLE EACH

1 FORCEPS WITH MAGNIFIER

1 SCISSOR UTILITY SHEARS 7-1/4"

1 SCISSOR LISTER BDG S/S 5 1/2"

2 BATTERY - RAYOVAC SIZE AA

2 BATTERY - SIZE D

1 BG POLY 32" x 34"

1 TONGUE BLADES SR. WRAPPED 12'S

1 SAFETY PINS LARGE #3 DOZ

6 SPLINT-CARDBOARD HAND & WRIST

4 SPLINT BOARD W/PAD SML 12"X6"

1 LBL STOCK 4"X2-7/8"

1 LBL CONTS 8"X8",CUSTOM ID B

1 LBL STOCK PLAIN 3.2"x7/8"

1 GRAINGER , DELUXE TRAUMA BAG

2 x5 PR LRG NITRILE GLVES ZIP BAG

4 EMER.YELLOW BLKT 54"X80" POLYP

1 ANTISEPTIC HAND GEL 4OZ

1 ANTISEPTIC WIPES 20'S ZIP LOCK

1 HYDROCORTISONE 20'S ZIP LOCK

1 ALCOHOL WIPES 50'S ZIP LOCK

4 COLD PACK 5"X 9" BULK

2 TRI BNDG NON WOVEN 40"X40"X56"

1 WOVEN KNUCKLE 8'S

1 FINGERTIP "T" 8/BX

Triple

Principal Display Panel

BZK Wipe

Principal Display Panel

Eyewash

Principal Display Panel

Hydrocortisone

Principal Display Panel

Hand Sanitizer

Principal Display Panel

Principal Display Panel 500 ml Container

Alcohol Wipe

Principal Display Panel

Ammonia Inhalent

Principal Display Panel

4381 Kit Label

14525

4382 Kit Label

Z145225

4393 Kit Label

Z19802

4382 FIRST AID KIT

4 382 first aid kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 49 8 -438 2

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -438 2-0 1

1 in 1 KIT

0 9 /13/20 18

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

1 BOTTLE

118 mL

Pa rt 2

20 PACKET

10 g

Pa rt 3

20 PACKET

28 mL

Pa rt 4

20 PACKET

18 g

Pa rt 5

1 BOTTLE, PLASTIC

118 mL

Pa rt 6

10 AMPULE

3 mL

Pa rt 7

50 POUCH

20 mL

Pa rt 8

1 CONTAINER

50 0 mL

Pa rt 9

20 PACKET

18 g

Part 1 of 9

EYESALINE EMERGENCY EYEWASH

purified water liquid

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 10 0

Route of Administration

OPHTHALMIC

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R) (WATER - UNII:0 59 QF0 KO0 R)

WATER

9 8 .6 mL in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

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

SO DIUM PHO SPHATE, MO NO BASIC, MO NO HYDRATE (UNII: 59 3YOG76 RN)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -0 10 0 -0 2

118 mL in 1 BOTTLE; 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 mo no graph final

pa rt349

12/18 /20 18

Part 2 of 9

TRIPLE ANTIBIOTIC

bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 750

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PO LYMYXIN B SULFATE (UNII: 19 371312D4) (POLYMYXIN B - UNII:J2VZ0 7J9 6 K)

POLYMYXIN B

50 0 0 [iU] in 1 g

BACITRACIN ZINC (UNII: 8 9 Y4M234ES) (BACITRACIN - UNII:58 H6 RWO52I)

BACITRACIN

40 0 [iU] in 1 g

NEO MYCIN SULFATE (UNII: 0 57Y6 26 6 9 3) (NEOMYCIN - UNII:I16 QD7X29 7)

NEOMYCIN

3.5 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

PETRO LATUM (UNII: 4T6 H12BN9 U)

Product Characteristics

Color

white

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -0 750 -36

0 .5 g in 1 PACKET; 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 mo no graph final

pa rt333B

0 9 /19 /20 18

Part 3 of 9

ANTISEPTIC TOWELETTE

benzalkonium chloride liquid

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 50 1

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -

UNII:7N6 JUD5X6 Y)

BENZALKONIUM

CHLORIDE

1.3 mg

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

NDC:0 49 8 -0 50 1-0 0

1.4 mL in 1 PACKET; 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 mo no graph no t final

pa rt333E

12/22/20 17

Part 4 of 9

HYDROCORTISONE

anti-itch cream ointment

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 8 0 0

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HYDRO CO RTISO NE ACETATE (UNII: 3X79 31PO74) (HYDROCORTISONE -

UNII:WI4X0 X7BPJ)

HYDROCORTISONE

ACETATE

in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

LIGHT MINERAL O IL (UNII: N6 K578 7QVP)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

DIAZO LIDINYL UREA (UNII: H5RIZ3MPW4)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

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

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

0 .9 g in 1 PACKET; 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 mo no graph no t final

pa rt348

0 3/0 6 /20 13

10 /15/20 19

Part 5 of 9

INSTANT HAND SANITIZER

alcohol liquid

Product Information

Ite m Code (Source )

NDC:59 8 9 8 -420

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)

ALCOHOL

6 2 mL in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

.ALPHA.-TO CO PHERO L ACETATE, DL- (UNII: WR1WPI7EW8 )

TRIISO PRO PANO LAMINE (UNII: W9 EN9 DLM9 8 )

CARBO MER CO PO LYMER TYPE A (UNII: 71DD5V9 9 5L)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:59 8 9 8 -420 -

118 mL in 1 BOTTLE, PLASTIC; 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

OTC mo no graph no t final

pa rt333E

0 4/15/20 10

Part 6 of 9

AMMONIA INHALENT

ammonia inhalent inhalant

Product Information

Ite m Code (Source )

NDC:0 49 8 -3334

Route of Administration

RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

AMMO NIA (UNII: 5138 Q19 F1X) (AMMONIA - UNII:5138 Q19 F1X)

AMMONIA

0 .0 45 g in 0 .3 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -3334-0 0

0 .3 mL in 1 AMPULE; 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

unappro ved drug o ther

0 9 /18 /20 18

Part 7 of 9

ALCOHOL WIPE

isopropyl alcohol swab

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 143

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

NDC:0 49 8 -0 143-0 4

0 .4 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 mo no graph no t final

pa rt333A

0 9 /18 /20 18

Part 8 of 9

SODIUM CHLORIDE

sodium chloride irrigant

Product Information

Ite m Code (Source )

NDC:0 26 4-220 1

Route of Administration

IRRIGATION

Active Ingredient/Active Moiety

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

0 .9 g

in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

HYDRO CHLO RIC ACID (UNII: QTT1758 2CB)

Packag ing

# Item Code

Package Description

Marketing Start Date

Marketing End Date

1

50 0 mL in 1 CONTAINER; 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

NDA0 16 733

0 9 /14/20 0 9

Part 9 of 9

HYDROCORTISONE

anti-itch cream

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 8 0 1

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HYDRO CO RTISO NE ACETATE (UNII: 3X79 31PO74) (HYDROCORTISONE -

UNII:WI4X0 X7BPJ)

HYDROCORTISONE

ACETATE

in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

LIGHT MINERAL O IL (UNII: N6 K578 7QVP)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

DIAZO LIDINYL UREA (UNII: H5RIZ3MPW4)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

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

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

0 .9 g in 1 PACKET; 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 mo no graph no t final

pa rt348

10 /15/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved drug o ther

0 9 /13/20 18

4381 FIRST AID KIT

4 381 first aid kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 49 8 -438 1

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -438 1-0 1

1 in 1 KIT

0 9 /13/20 18

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

20 PACKET

18 g

Pa rt 2

1 BOTTLE

118 mL

Pa rt 3

20 PACKET

10 g

Pa rt 4

20 PACKET

28 mL

Pa rt 5

20 PACKET

18 g

Pa rt 6

1 BOTTLE, PLASTIC

118 mL

Pa rt 7

10 AMPULE

3 mL

Pa rt 8

50 POUCH

20 mL

Pa rt 9

1 CONTAINER

50 0 mL

Part 1 of 9

HYDROCORTISONE

anti-itch cream

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 8 0 1

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HYDRO CO RTISO NE ACETATE (UNII: 3X79 31PO74) (HYDROCORTISONE -

UNII:WI4X0 X7BPJ)

HYDROCORTISONE

ACETATE

in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

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

LIGHT MINERAL O IL (UNII: N6 K578 7QVP)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

DIAZO LIDINYL UREA (UNII: H5RIZ3MPW4)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

0 .9 g in 1 PACKET; 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 mo no graph no t final

pa rt348

10 /15/20 19

Part 2 of 9

EYESALINE EMERGENCY EYEWASH

purified water liquid

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 10 0

Route of Administration

OPHTHALMIC

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R) (WATER - UNII:0 59 QF0 KO0 R)

WATER

9 8 .6 mL in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

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

SO DIUM PHO SPHATE, MO NO BASIC, MO NO HYDRATE (UNII: 59 3YOG76 RN)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -0 10 0 -0 2

118 mL in 1 BOTTLE; 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 mo no graph final

pa rt349

12/18 /20 18

Part 3 of 9

TRIPLE ANTIBIOTIC

bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 750

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PO LYMYXIN B SULFATE (UNII: 19 371312D4) (POLYMYXIN B - UNII:J2VZ0 7J9 6 K)

POLYMYXIN B

50 0 0 [iU] in 1 g

BACITRACIN ZINC (UNII: 8 9 Y4M234ES) (BACITRACIN - UNII:58 H6 RWO52I)

BACITRACIN

40 0 [iU] in 1 g

NEO MYCIN SULFATE (UNII: 0 57Y6 26 6 9 3) (NEOMYCIN - UNII:I16 QD7X29 7)

NEOMYCIN

3.5 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

PETRO LATUM (UNII: 4T6 H12BN9 U)

Product Characteristics

Color

white

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -0 750 -36

0 .5 g in 1 PACKET; 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 mo no graph final

pa rt333B

0 9 /19 /20 18

Part 4 of 9

ANTISEPTIC TOWELETTE

benzalkonium chloride liquid

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 50 1

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -

UNII:7N6 JUD5X6 Y)

BENZALKONIUM

CHLORIDE

1.3 mg

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

NDC:0 49 8 -0 50 1-0 0

1.4 mL in 1 PACKET; 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 mo no graph no t final

pa rt333E

12/22/20 17

Part 5 of 9

HYDROCORTISONE

anti-itch cream ointment

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 8 0 0

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HYDRO CO RTISO NE ACETATE (UNII: 3X79 31PO74) (HYDROCORTISONE -

UNII:WI4X0 X7BPJ)

HYDROCORTISONE

ACETATE

in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

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

LIGHT MINERAL O IL (UNII: N6 K578 7QVP)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

DIAZO LIDINYL UREA (UNII: H5RIZ3MPW4)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

0 .9 g in 1 PACKET; 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 mo no graph no t final

pa rt348

0 3/0 6 /20 13

10 /15/20 19

Part 6 of 9

INSTANT HAND SANITIZER

alcohol liquid

Product Information

Ite m Code (Source )

NDC:59 8 9 8 -420

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)

ALCOHOL

6 2 mL in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

.ALPHA.-TO CO PHERO L ACETATE, DL- (UNII: WR1WPI7EW8 )

TRIISO PRO PANO LAMINE (UNII: W9 EN9 DLM9 8 )

CARBO MER CO PO LYMER TYPE A (UNII: 71DD5V9 9 5L)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:59 8 9 8 -420 -

118 mL in 1 BOTTLE, PLASTIC; 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

OTC mo no graph no t final

pa rt333E

0 4/15/20 10

Part 7 of 9

AMMONIA INHALENT

ammonia inhalent inhalant

Product Information

Ite m Code (Source )

NDC:0 49 8 -3334

Route of Administration

RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

AMMO NIA (UNII: 5138 Q19 F1X) (AMMONIA - UNII:5138 Q19 F1X)

AMMONIA

0 .0 45 g in 0 .3 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -3334-0 0

0 .3 mL in 1 AMPULE; 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

unappro ved drug o ther

0 9 /18 /20 18

Part 8 of 9

ALCOHOL WIPE

isopropyl alcohol swab

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 143

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

NDC:0 49 8 -0 143-0 4

0 .4 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 mo no graph no t final

pa rt333A

0 9 /18 /20 18

Part 9 of 9

SODIUM CHLORIDE

sodium chloride irrigant

Product Information

Ite m Code (Source )

NDC:0 26 4-220 1

Route of Administration

IRRIGATION

Active Ingredient/Active Moiety

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

0 .9 g

in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

HYDRO CHLO RIC ACID (UNII: QTT1758 2CB)

Packag ing

# Item Code

Package Description

Marketing Start Date

Marketing End Date

1

50 0 mL in 1 CONTAINER; 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

NDA0 16 733

0 9 /14/20 0 9

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved drug o ther

0 9 /13/20 18

4393 FIRST AID KIT

4 393 first aid kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 49 8 -439 3

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -439 3-0 1

1 in 1 KIT

0 9 /13/20 18

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

20 PACKET

18 g

Pa rt 2

1 BOTTLE

118 mL

Pa rt 3

20 PACKET

10 g

Pa rt 4

20 PACKET

28 mL

Pa rt 5

20 PACKET

18 g

Pa rt 6

1 BOTTLE, PLASTIC

118 mL

Pa rt 7

10 AMPULE

3 mL

Pa rt 8

50 POUCH

20 mL

Pa rt 9

1 CONTAINER

50 0 mL

Part 1 of 9

HYDROCORTISONE

anti-itch cream

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 8 0 1

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HYDRO CO RTISO NE ACETATE (UNII: 3X79 31PO74) (HYDROCORTISONE -

UNII:WI4X0 X7BPJ)

HYDROCORTISONE

ACETATE

in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

LIGHT MINERAL O IL (UNII: N6 K578 7QVP)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

DIAZO LIDINYL UREA (UNII: H5RIZ3MPW4)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

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

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

0 .9 g in 1 PACKET; 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 mo no graph no t final

pa rt348

10 /15/20 19

Part 2 of 9

EYESALINE EMERGENCY EYEWASH

purified water liquid

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 10 0

Route of Administration

OPHTHALMIC

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R) (WATER - UNII:0 59 QF0 KO0 R)

WATER

9 8 .6 mL in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

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

SO DIUM PHO SPHATE, MO NO BASIC, MO NO HYDRATE (UNII: 59 3YOG76 RN)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -0 10 0 -0 2

118 mL in 1 BOTTLE; 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 mo no graph final

pa rt349

12/18 /20 18

Part 3 of 9

TRIPLE ANTIBIOTIC

bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 750

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PO LYMYXIN B SULFATE (UNII: 19 371312D4) (POLYMYXIN B - UNII:J2VZ0 7J9 6 K)

POLYMYXIN B

50 0 0 [iU] in 1 g

BACITRACIN ZINC (UNII: 8 9 Y4M234ES) (BACITRACIN - UNII:58 H6 RWO52I)

BACITRACIN

40 0 [iU] in 1 g

NEO MYCIN SULFATE (UNII: 0 57Y6 26 6 9 3) (NEOMYCIN - UNII:I16 QD7X29 7)

NEOMYCIN

3.5 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

PETRO LATUM (UNII: 4T6 H12BN9 U)

Product Characteristics

Color

white

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -0 750 -36

0 .5 g in 1 PACKET; 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 mo no graph final

pa rt333B

0 9 /19 /20 18

Part 4 of 9

ANTISEPTIC TOWELETTE

benzalkonium chloride liquid

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 50 1

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -

UNII:7N6 JUD5X6 Y)

BENZALKONIUM

CHLORIDE

1.3 mg

in 1 mL

UNII:7N6 JUD5X6 Y)

CHLORIDE

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

NDC:0 49 8 -0 50 1-0 0

1.4 mL in 1 PACKET; 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 mo no graph no t final

pa rt333E

12/22/20 17

Part 5 of 9

HYDROCORTISONE

anti-itch cream ointment

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 8 0 0

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HYDRO CO RTISO NE ACETATE (UNII: 3X79 31PO74) (HYDROCORTISONE -

UNII:WI4X0 X7BPJ)

HYDROCORTISONE

ACETATE

in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

LIGHT MINERAL O IL (UNII: N6 K578 7QVP)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

DIAZO LIDINYL UREA (UNII: H5RIZ3MPW4)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

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

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

0 .9 g in 1 PACKET; 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 mo no graph no t final

pa rt348

0 3/0 6 /20 13

10 /15/20 19

Part 6 of 9

INSTANT HAND SANITIZER

alcohol liquid

Product Information

Ite m Code (Source )

NDC:59 8 9 8 -420

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)

ALCOHOL

6 2 mL in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

.ALPHA.-TO CO PHERO L ACETATE, DL- (UNII: WR1WPI7EW8 )

TRIISO PRO PANO LAMINE (UNII: W9 EN9 DLM9 8 )

CARBO MER CO PO LYMER TYPE A (UNII: 71DD5V9 9 5L)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:59 8 9 8 -420 -

118 mL in 1 BOTTLE, PLASTIC; 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

OTC mo no graph no t final

pa rt333E

0 4/15/20 10

Part 7 of 9

AMMONIA INHALENT

ammonia inhalent inhalant

Product Information

Ite m Code (Source )

NDC:0 49 8 -3334

Route of Administration

RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

AMMO NIA (UNII: 5138 Q19 F1X) (AMMONIA - UNII:5138 Q19 F1X)

AMMONIA

0 .0 45 g in 0 .3 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -3334-0 0

0 .3 mL in 1 AMPULE; 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

unappro ved drug o ther

0 9 /18 /20 18

Part 8 of 9

ALCOHOL WIPE

isopropyl alcohol swab

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 143

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

NDC:0 49 8 -0 143-0 4

0 .4 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 mo no graph no t final

pa rt333A

0 9 /18 /20 18

Part 9 of 9

SODIUM CHLORIDE

sodium chloride irrigant

Product Information

Ite m Code (Source )

NDC:0 26 4-220 1

Route of Administration

IRRIGATION

Active Ingredient/Active Moiety

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

0 .9 g

in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

HYDRO CHLO RIC ACID (UNII: QTT1758 2CB)

Packag ing

# Item Code

Package Description

Marketing Start Date

Marketing End Date

1

50 0 mL in 1 CONTAINER; 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

NDA0 16 733

0 9 /14/20 0 9

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved drug o ther

0 9 /13/20 18

Labeler -

Honeywell Safety Products USA, Inc. (079287321)

Registrant -

Honeywell Safety Products USA, Inc. (079287321)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

B. Braun Medical Inc.

0 3742530 8

la be l(0 26 4-220 1)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

James Alexander

0 40 756 421

ma nufa c ture (0 49 8 -3334)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ho neywell Safety Pro ducts USA, Inc

0 79 28 7321

pack(0 49 8 -438 1, 0 49 8 -438 2, 0 49 8 -439 3)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Water-Jel Techno lo gies

15552258 9

manufacture(0 49 8 -0 750 , 0 49 8 -0 8 0 0 , 59 8 9 8 -420 , 0 49 8 -0 8 0 1)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ho neywell Safety Pro ducts USA, Inc.

16 7518 6 17

ma nufa c ture (0 49 8 -0 10 0 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Changzho u Mao kang Medical

4213170 73

manufacture(0 49 8 -0 50 1, 0 49 8 -0 143)

Honeywell Safety Products USA, Inc.

Revised: 10/2019

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