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Bacitracin zinc by Qualitest Pharmaceuticals

Dosage form: ointment
Ingredients: BACITRACIN ZINC 500[USP'U] in 1g
Labeler: Qualitest Pharmaceuticals
NDC Code: 0603-0441

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


First aid antibiotic


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

  • cuts
  • scrapes
  • burns


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.

  • 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

bacitracin zinc ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0603-0441
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Inactive Ingredients
Ingredient NameStrength
#Item CodePackage Description
1NDC:0603-0441-501 TUBE in 1 CARTON
128.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333B09/01/200105/31/2018
Labeler - Qualitest Pharmaceuticals (011103059)
Vintage Pharmaceuticals-Huntsville825839835MANUFACTURE(0603-0441)

Revised: 08/2015
Qualitest Pharmaceuticals

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.