BACITRACIN - bacitracin zinc ointment 
Qualitest Pharmaceuticals

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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Active ingredient (in each gram)

Bacitracin zinc, USP 500 units

Purpose

First aid antibiotic

Uses

First aid to help reduce the risk of infection in minor:

Warnings

For external use only

Do not use if you are allergic to any of the ingredients

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

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive ingredients

mineral oil, white petrolatum

Made in the USA
for Qualitest Pharmaceuticals
Huntsville, AL 35811

Rev. 9/11 R6
8260300  0441

PRINCIPAL DISPLAY PANEL

This is an image of the carton for Bacitracin Zinc Ointment, USP.


BACITRACIN 
bacitracin ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0603-0441
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (BACITRACIN) BACITRACIN ZINC500 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL 
PETROLATUM 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:0603-0441-501 TUBE (1 TUBE) in 1 CARTONcontains a TUBE
128.4 g in 1 TUBEThis package is contained within the CARTON (0603-0441-50)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333B09/01/2001

Labeler - Qualitest Pharmaceuticals (011103059)
Establishment
NameAddressID/FEIOperations
Vintage Pharmaceuticals-Huntsville825839835MANUFACTURE

Revised: 04/2012 Qualitest Pharmaceuticals