BACITRACIN ZINC- bacitracin zinc 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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Bacitracin Zinc Ointment_OTC

ACTIVE INGREDIENT (in each gram)

Bacitracin zinc, USP 500 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 room temperature 59°-77°F (15°-25°C).   •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 0472-1105-34
Bacitracin Zinc Ointment, USP
First Aid Antibiotic

Prevents Infection in Minor Curts, Scrapes, and Burns

New wt. 0.5 oz (14g)

Bacitracin Zinc Ointment
BACITRACIN ZINC 
bacitracin zinc ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0472-1105
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0472-1105-341 in 1 CARTON06/01/199701/31/2023
114 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:0472-1105-261 in 1 CARTON06/01/199701/31/2023
228 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:0472-1105-561 in 1 CARTON06/01/199701/31/2023
328 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B06/01/199701/31/2023
Labeler - Actavis Pharma, Inc. (119723554)

Revised: 9/2022
 
Actavis Pharma, Inc.