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Bacitracin by Trifecta Pharmaceuticals USA, LLC.

Dosage form: ointment
Ingredients: BACITRACIN ZINC 500[USP'U] in 1g
Labeler: Trifecta Pharmaceuticals USA, LLC.
NDC Code: 69396-027

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

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, longer than 1 week unless directed by a healthcare professional

Ask a Healthcare Professional before use in care of deep or 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 vera gel, light mineral oil, white petrolatum

Other Information

Store between 15º to 25ºC (59º to 77ºF)

Lot No and Expiration Dates - please see box and tube crimp

100% GUARANTEED

Distributed By:

Trifecta Pharmaceuticals USA ™

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301 USA

Product of PRC

www.trifecta-pharma.com

Keep out of reach of children

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

Packaging

BACITRACIN 
bacitracin zinc ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-027
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (BACITRACIN) BACITRACIN500 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
LIGHT MINERAL OIL 
PETROLATUM 
ALOE VERA LEAF 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:69396-027-011 TUBE in 1 BOX
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B03/15/2017
Labeler - Trifecta Pharmaceuticals USA, LLC. (079424163)

Revised: 11/2017
 
Trifecta Pharmaceuticals USA, LLC.

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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.

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