Label: BACITRACIN ZINC ointment

  • 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 April 7, 2016

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  • Drug Facts

  • Active ingredient

    Bacitracin Zinc 500 units

  • Purpose

    First Aid Antibiotic

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • Uses

    ● first aid to help prevent infection in ● minor cuts ● scrapes ● burns

  • Warnings

    For external use only.

    Do not use ● in the 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 a healthcare professional 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 ingredient:

    aloe vera gel, light mineral oil, white petrolatum

  • Other information

    ● store between15° to 25°C ( 59° to 77°F) ● Lot No & Expiration Date: See box and tube crimp.

  • SPL UNCLASSIFIED SECTION

    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

  • Packaging

    bacitracin 500

  • INGREDIENTS AND APPEARANCE
    BACITRACIN ZINC 
    bacitracin zinc ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-008
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-008-201 in 1 BOX04/07/2016
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B04/07/2016
    Labeler - Trifecta Pharmaceuticals Usa Llc (079424163)
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