TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment

Triple Antibiotic by

Drug Labeling and Warnings

Triple Antibiotic by is a Otc medication manufactured, distributed, or labeled by Acme United Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Bacitracin zinc 400 units

Neomycin sulfate 5 mg (equivalent to 3.5 mg. of neomycin base)

Polymyxin - B sulfate 5000 units

Active ingredient (in each gram)	Purpose
Bacitracin Zinc 400 Units	First Aid Antibiotic
Neomycin Sulfate 5mg (Equivalent to 3.5 mg of Neomycin base)	First Aid Antibiotic
Polymyxin B Sulfate 5000 Units	First Aid Antibiotic

USES

First aid to help prevent infection in minor:

• cuts
• scrapes
• burns

WARNINGS

For external use only

DO NOT USE

Do not use in the eyes over large areas of the body if you are allergic to any of the ingredients

longer than 1 week unless directed by a doctor on deep lacerations or puncture wounds, animal bites, or serious burns

STOP USE AND ASK A DOCTOR IF

condition persists or gets worse a rash or allergic reaction occurs

condition persists for more than 7 days

Keep out the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

DIRECTIONS

Adults and Children Clean the affected area. Apply a small amount of product

(equal to the surface area of a fingertip) 1 to 3 times daily. May be covered with a sterile bandage.

OTHER INFORMATION

Store at 15°- 30°C (59°- 86°F)

INACTIVE INGREDIENT

White Petrolatum

QUESTIONS

Questions 1.800.835.2263

PRINCIPAL DISPLAY PANEL

Carton Image

INGREDIENTS AND APPEARANCE

TRIPLE ANTIBIOTIC 
bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0924-5610(NDC:50382-023)
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0924-5610-02	25 in 1 CARTON	08/05/2022
1		0.5 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 0924-5610-00	0.5 g in 1 PACKET; Type 0: Not a Combination Product	08/05/2022
3	NDC: 0924-5610-01	12 in 1 CARTON	08/05/2022
3		0.5 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	08/04/2022

Labeler - Acme United Corporation (001180207)

Establishment
Name	Address	ID/FEI	Business Operations
Acme United Corporation		045924339	repack(0924-5610) , relabel(0924-5610)

Establishment
Name	Address	ID/FEI	Business Operations
Acme United Corporation		080119599	repack(0924-5610) , relabel(0924-5610)