BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE ointment

Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate by

Drug Labeling and Warnings

Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate by is a Otc medication manufactured, distributed, or labeled by Henry Schein, Dynarex. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Bacitracin Zinc 400 units

Neomyxin Sulfate 5mg (Equivalent to 3.5mg Neomycin)

Polymyxin B Sulfate 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 or over large areas of the body

If you are allergic to any of the ingredients

Longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

Deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if

The 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 (1-800-222-1222) right away.

Directions

Clean the 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 room temperature 15º-30ºC (59º-86°F)

Tamper evident. Do not use if seal is torn, cut, or opened.

Inactive Ingredients

White Petrolatum

Label

Triple Antibiotic Label

INGREDIENTS AND APPEARANCE

BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE 
bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0404-0167
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN ZINC	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
WHITE PETROLATUM (UNII: B6E5W8RQJ4)

Product Characteristics
Color		Score
Shape	FREEFORM	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0404-0167-50	1728 in 1 CASE	11/03/2022
1		144 in 1 BOX
1		0.9 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	11/03/2022

Labeler - Henry Schein (012430880)

Registrant - Dynarex (008124539)