BACITRACIN ZINC- 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.

----------

Bacitracin Zinc Ointment, USP

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:

  • cuts
  • scrapes
  • burns

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

  • deep or puncture wounds
  • animal bites
  • serious burns

When using this product

  • do not use in the eyes
  • do not apply over large areas of the body

Stop use and ask a doctor if

  • you need to use more than 1 week
  • condition persists or gets worse
  • 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 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 15°- 30°C (59°- 86°F)
  • lot number and expiration date: See crimp of tube or box

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. 5/15 R7
8260300  0441

PRINCIPAL DISPLAY PANEL

This is an image of the carton for Bacitracin Zinc Ointment, USP.
BACITRACIN ZINC 
bacitracin zinc ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0603-0441
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
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0603-0441-501 in 1 CARTON09/01/200105/31/2018
128.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333B09/01/200105/31/2018
Labeler - Qualitest Pharmaceuticals (011103059)
Establishment
NameAddressID/FEIBusiness Operations
Vintage Pharmaceuticals-Huntsville825839835MANUFACTURE(0603-0441)

Revised: 8/2015
 
Qualitest Pharmaceuticals