Bacitracin Zinc: Package Insert and Label Information

BACITRACIN ZINC- bacitracin zinc ointment
Chain Drug Marketing Association 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.

Active Ingredient

Bacitracin Zinc 500 Units


First Aid Antibiotic


First Aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns


For External Use Only.

Do Not Use

  • in eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than 1 week unless directed by a doctor

Ask Doctor before Use

In care of deep puncture wounds, animal bites, or serious burns.

Stop Use and Ask Doctor if

  • The condition persists or gets worse
  • A rash or allergic reaction develops


  • 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

Inactive Ingredients

Aloe barbadensis leaf juice, mineral oil, petrolatum

Keep out of reach of children

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

Other Information

Store Between 15° to 25°C (59° to 77°F)

Lot No. and Exp. date: see box and tube crimp

Distributed By:

C.D.M.A, Inc. ©

43157 W 9 Mile Rd

Novi, MI. 48375


Product of PRC


qc bacitracin 1oz
(click image for full-size original)

bacitracin zinc ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-574
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Inactive Ingredients
Ingredient Name Strength
# Item Code Package Description Multilevel Packaging
1 NDC:63868-574-01 1 TUBE in 1 BOX contains a TUBE
1 28.3 g in 1 TUBE This package is contained within the BOX (63868-574-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333B 06/11/2020
Labeler — Chain Drug Marketing Association Inc. (011920774)
Registrant — Trifecta Pharmaceuticals USA LLC (079424163)

Revised: 02/2021 Chain Drug Marketing Association Inc. provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.