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

Purpose

First Aid Antibiotic

Uses

First Aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns

Warnings

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

Directions

  • 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

Questions

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:

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive

Suite 233

Livonia, MI 48152

Product of USA

Packaging

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

MAJOR BACITRACIN
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
BACITRACIN ZINC (BACITRACIN) BACITRACIN 500 [USP’U] in 1 g
Inactive Ingredients
Ingredient Name Strength
PETROLATUM
MINERAL OIL
Packaging
# 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

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