BACITRACIN ZINC OINTMENT [TRIFECTA PHARMACEUTICALS USA LLC]

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BACITRACIN ZINC OINTMENT [TRIFECTA PHARMACEUTICALS USA LLC]
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NDC 69396-008-20
Set ID 0a970384-1155-400b-9c73-c3e4563788be
Category HUMAN OTC DRUG LABEL
Packager Trifecta Pharmaceuticals Usa Llc
Generic Name
Product Class
Product Number
Application Number PART333B
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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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