Label: BACITRACIN- bacitracin zinc ointment

  • NDC Code(s): 69396-027-01
  • Packager: Trifecta Pharmaceuticals USA, LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated September 27, 2023

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  • 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 doctor.

    .

  • 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

    www.trifecta-pharma.com

  • Keep out of reach of children

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

  • Ask

  • PRINCIPAL DISPLAY PANEL

    4028 GLOBE BACITRACIN ZINC OINTMENT 1OZ REV04 060523 CDER

  • INGREDIENTS AND APPEARANCE
    BACITRACIN 
    bacitracin zinc ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-027
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-027-011 in 1 BOX03/15/2017
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B03/15/2017
    Labeler - Trifecta Pharmaceuticals USA, LLC. (079424163)
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