BACITRACIN ZINC- bacitracin zinc ointment 
Aidarex Pharmaceuticals LLC

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, USP

ACTIVE INGREDIENT

(in each gram)

Bacitracin zinc, USP 500 units

PURPOSE

First aid antibiotic

USES

Helps prevent infection in

WARNINGS

For external use only

Allergy alert:

DO NOT USE

ASK A DOCTOR BEFORE USE IF YOU HAVE

WHEN USING THIS PRODUCT

STOP USE AND ASK A DOCTOR IF

KEEP OUT OF REACH OF CHILDREN

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

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENT

White petrolatum

QUESTIONS?

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Repackaged By:
Aidarex Pharmaceuticals, LLC
Corona, CA 92880

NDC 33261-707-01

Bacitracin Zinc Ointment, USP

First Aid Antibiotic Ointment

Net WT 1 OZ (28 g)

11051210E1                VC110188

Image Label

Image Label

BACITRACIN ZINC 
bacitracin zinc ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33261-707(NDC:0472-1105)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC500 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33261-707-561 in 1 CARTON
1NDC:33261-707-0128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333B03/01/2002
Labeler - Aidarex Pharmaceuticals LLC (801503249)

Revised: 9/2012
Document Id: a9c631b4-b783-4a4b-9b9e-f79bb60a7437
Set id: aee808f9-e759-4129-9661-29c2a3bd9a30
Version: 1
Effective Time: 20120910
 
Aidarex Pharmaceuticals LLC