Genuine Triple Antibiotic

Genuine Triple Antibiotic by

Drug Labeling and Warnings

Genuine Triple Antibiotic by is a Otc medication manufactured, distributed, or labeled by GFA Production (Xiamen) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GENUINE TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b sulfate cream 
GFA Production (Xiamen) Co., Ltd.

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Genuine Triple Antibiotic

Drug Facts

Each Gram Contains:

Bacitracin Zinc 400 units

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

Polymyxin B Sulfate 5000 units

Purpose:

Uses:

To help prevent infections in minor cuts, scrapes or burns.

Warnings:

For external use only

Do not use:

in eyes, over large areas of the body, if allergic to any of the ingredients, or for more than one week unless directed by a physician.

Stop use and consult a doctor:

if the condition persists or gets worse, a rash or other allergic reaction develops.

Keep out of reach of children:

If ingested, contact a Poison Control Center right away.

Directions:

Clean affected area, apply small amount of this 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.

Other information:

Store at room temperature.

Inactive ingredient:

Vaseline 96.41 %

Mineral oil 2%

Purified water.

Package Labeling:

GENUINE TRIPLE ANTIBIOTIC 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50814-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	400 U  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	5000 U  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50814-003-01	1 in 1 BOX	03/23/2016	12/31/2025
1		0.9 g in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M004	03/23/2016	12/31/2025

Labeler - GFA Production (Xiamen) Co., Ltd. (421256261)

Revised: 10/2024

Document Id: 24068fcf-35cb-b705-e063-6394a90a4e7d

34390-5

Set id: 901c105e-71b1-4268-bef6-eb310d4a734c

Version: 7

Effective Time: 20241009