Major Bacitracin: Package Insert and Label Information

MAJOR BACITRACIN- bacitracin zinc ointment
Major 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.

Active Ingredient

Bacitracin Zinc 500 Units per gram


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, due to the possiblity of anaphylactic shock
  • 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

  • Before use in case of deep puncture wounds, animal bites or serious burns
  • The condition persists or gets worse
  • A rash or allergic reaction develops


  • Clean the affected area
  • Apply a small amount of the 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

mineral oil, white petrolatum


Call 1-800-616-2471

Storage Information

Avoid excessive heat and humidity

Store at room temperature 15° to 30°C (59° to 86°F).

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Other Information

Tamper evident. Do not use if packet is torn, cut or opened.

Distributed By:


17177 N Laurel Park Drive

Suite 233

Livonia, MI 48152

Product of USA


701208_Bacitracin Zinc Packet
(click image for full-size original)

bacitracin zinc ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-7023
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:0904-7023-67 144 PACKET in 1 CARTON contains a PACKET
1 0.9 g in 1 PACKET This package is contained within the CARTON (0904-7023-67)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333B 04/01/2020
Labeler — Major Pharmaceuticals (191427277)
Registrant — Trifecta Pharmaceuticals USA LLC (079424163)

Revised: 05/2020 Major Pharmaceuticals 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.

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