TRIPLE ANTIBIOTIC- bacitracin zinc neomycin sulfate polymyxin b sulfate ointment
Actavis Pharma, Inc.

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.

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Triple Antibiotic Ointment (Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate)

Drug Facts

Active ingredients (in each gram)

Bacitracin zinc, USP 400 units
Neomycin 3.5 mg
Polymyxin B sulfate, USP 5,000 units

Purpose

First aid antibiotic

Uses

First aid to help prevent infection in

minor cuts
scrapes
burns

Warnings

For external use only

Allergy alert:

do not use if 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

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 ask a doctor if

condition persists or gets worse
a rash or other allergic reaction develops

Keep out of reach of children.

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

Directions

clean affected area
apply a 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 controlled room temperature 59°-86°F (15°-30°C). Protect from freezing.
Before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredient

white petrolatum

Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday–Friday.

Principal Display Panel

Actavis
NDC 0472-0179-34
Compare to the active ingredients in Neosporin®*

Triple Antibiotic Ointment
(Bacitracin Zinc – Neomycin Sulfate – Polymyxin B Sulfate Ointment)
First Aid Antibiotic
First Aid to Help Prevent Infection in Minor Cuts, Scrapes and Burns

Protection Against Infection
For Minor Cuts, Scrapes, and Burns

Net wt. 0.5 oz (14g)

Triple Antibiotic Oinment

TRIPLE ANTIBIOTIC
bacitracin zinc neomycin sulfate polymyxin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0472-0179
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	Marketing End Date
Packaging
1	NDC:0472-0179-34	1 in 1 CARTON	05/01/1997	09/30/2022
1		14 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:0472-0179-56	1 in 1 CARTON	05/01/1997	04/30/2022
2		28 g in 1 TUBE; 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	05/01/1997	09/30/2022

Labeler - Actavis Pharma, Inc. (119723554)

Revised: 9/2022

Document Id: fd86b484-bdb0-4119-8efb-818b0f9ce1ac

Set id: 2d406fb8-2730-45cc-92e8-f8fa603b95f8

Version: 9

Effective Time: 20220923

Actavis Pharma, Inc.