GLINT TRIPLE ANTIBIOTIC FIRST AID (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) OINTMENT [GLINT COSMETICS PRIVATE LIMITED]

GLINT TRIPLE ANTIBIOTIC FIRST AID (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) OINTMENT [GLINT COSMETICS PRIVATE LIMITED]
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NDC 71486-3025-2, 71486-3025-3, 71486-3025-4, 71486-3025-5
Set ID 64e34b3f-85d8-62ad-e053-2991aa0ad67f
Category HUMAN OTC DRUG LABEL
Packager GLINT COSMETICS PRIVATE LIMITED
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
  • Active ingredients (in each gram)

    Bacitracin Zinc 400 units

    Neomycin Sulfate 5 mg (Equivalent to 3.5 mg Neomycin)

    Polymyxin B sulfate 5000 units

  • Purpose

    First Aid AntibioticFirst Aid AntibioticFirst Aid Antibiotic

  • Uses

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

  • Warnings

    For external use only

  • Do not use

    ■ in the eyes ■ if you are allergic to any of the ingredients ■ over large areas of the body ■ longer than 1 week unless directed by a doctor

  • Ask a physician before use in case of

    ■ deep or puncture wounds ■ animal bites ■ serious burns

  • Stop use and consult a doctor if

    ■ the condition persists or gets worse ■ a rash or other allergic reaction develops

  • KEEP OUT OF REACH OF CHILDREN

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

  • 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

  • Other Information

    ■ store at room temperature 15-30C (59-86F) ■ avoid excessive heat and humidity

  • Inactive ingredients

    white petrolatum

  • Package Label

    principal display

  • INGREDIENTS AND APPEARANCE
    GLINT TRIPLE ANTIBIOTIC  FIRST AID
    bacitracin zinc neomycin sulfate polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71486-3025
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [USP'U]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71486-3025-20.5 g in 1 PACKET; Type 0: Not a Combination Product05/17/2013
    2NDC:71486-3025-30.9 g in 1 PACKET; Type 0: Not a Combination Product05/17/2013
    3NDC:71486-3025-414 g in 1 TUBE; Type 0: Not a Combination Product05/17/2013
    4NDC:71486-3025-528.3 g in 1 TUBE; Type 0: Not a Combination Product05/17/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B05/17/2013
    Labeler - GLINT COSMETICS PRIVATE LIMITED (675910492)
    Establishment
    NameAddressID/FEIBusiness Operations
    GLINT COSMETICS PRIVATE LIMITED675910492manufacture(71486-3025)

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