TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
Acme United Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

First Aid Only Triple Antibiotic Ointment

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

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

Box Label

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333B	04/24/2023

Labeler - Acme United Corporation (001180207)

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

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