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

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
  • 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

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

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

www.qualitychoice.com

1-800-935-2362

Product of PRC

Packaging

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

BACITRACIN ZINC
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
BACITRACIN ZINC (BACITRACIN) BACITRACIN 500 [USP’U] in 1 g
Inactive Ingredients
Ingredient Name Strength
LIGHT MINERAL OIL
PETROLATUM
ALOE VERA LEAF
Packaging
# 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.

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