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

Drug Labeling and Warnings

Drug Details [pdf]

TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin-b sulfate ointment 
Fred's 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.

Pricipal Display Panel

fred's Pharmacy

NDC: 55315-179-56
PROTECTS AGAINST INFECTION

TRIPLE ANTIBIOTIC OINTMENT
(BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE OINTMENT)
FIRST AID ANTIBIOTIC

Compare To The Active Ingredients In: *Neosporin®

NET WT 1 OZ (28g)

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55315-179
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: 55315-179-56	1 in 1 CARTON	05/01/2009	09/30/2019
1		28 g in 1 TUBE; 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	05/01/2009	09/30/2019

Labeler - Fred's Inc. (005866116)

Registrant - Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 11/2017

Document Id: 9daca9b7-54e4-4ac7-8483-c7b1a6db20b8

34390-5

Set id: 2a6292d9-0617-4765-bff9-40948cc65371

Version: 6

Effective Time: 20171115

 

Fred's Inc.