TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, 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]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient (in each gram)

Bacitracin Zinc (400 units Bacitracin)

Neomycin Sulfate (3.5 mg Neomycin)

Polymyxin B Sulfate (Polymyxin B 5000 units)

Purpose

First Aid Antibiotic

First Aid Antibiotic

First Aid Antibiotic

Uses

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

Warnings

For external use only

Do not use:

• in the eyes
• over large areas of the body
• on puncture wounds, animal bites, or serious burns
• longer than 1 week unless directed by a doctor
• if you are allergic to any of the ingredients

Stop use and ask a doctor if:

• a rash or allergic reaction develops
• condition worsens or persists

Keep out the reach of children.

Directions

• Clean the affected area.
• Apply a small amount of product 1 to 3 times daily
• may be covered with a sterile bandage

Inactive Ingredient

White Petrolatum

Questions

1-800-835-2263

PRINCIPAL DISPLAY PANEL

Box Label

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0924-5604(NDC:61010-5603)
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	3.5 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: 0924-5604-00	0.5 g in 1 POUCH; Type 0: Not a Combination Product	04/24/2023
2	NDC: 0924-5604-01	6 in 1 BAG	04/24/2023
2		0.5 g in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 0924-5604-03	12 in 1 BOX	04/24/2023
3		0.5 g in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 0924-5604-02	10 in 1 BOX	04/24/2023
4		0.5 g in 1 PACKET; Type 0: Not a Combination Product
5	NDC: 0924-5604-04	20 in 1 BOX	04/24/2023
5		0.5 g in 1 PACKET; Type 0: Not a Combination Product
6	NDC: 0924-5604-05	25 in 1 BOX	04/24/2023
6		0.5 g in 1 PACKET; Type 0: Not a Combination Product
7	NDC: 0924-5604-06	60 in 1 BOX	04/24/2023
7		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 Drug	M004	04/24/2023

Labeler - Acme United Corporation (001180207)

Establishment
Name	Address	ID/FEI	Business Operations
Acme United Corporation		045924339	relabel(0924-5604) , repack(0924-5604)

Establishment
Name	Address	ID/FEI	Business Operations
Acme United Corporation		080119599	relabel(0924-5604) , repack(0924-5604)