Label: TRIPLE ANTIBIOTIC FIRST AID ANTIBIOTIC- bacitracin zinc, neomycin and polymyxin b sulfate ointment

  • NDC Code(s): 52000-056-02
  • Packager: Universal Distribution Center LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 14, 2024

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  • ACTIVE INGREDIENT

    Active Ingredients

    Bacitracin Zinc 400U

    Neomycin 3.5 mg

    Polymyxin B Sulfate 5000U

  • PURPOSE

    Purpose

    First Aid Antibiotic

  • INDICATIONS & USAGE

    Uses

    first aid to help prevent infection in

    • minor cuts
    • scrapes
    • burns
  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use

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

    Ask a doctor before use on

    • on deep puncture wounds, animal bites, or serious burns
  • STOP USE

    Stop use and consult a doctorif the condition persists or gets worse, or if 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.

  • DOSAGE & ADMINISTRATION

    Directions

    • Clean the affected area and dry thoroughly
    • May be covered with a sterile bandage
    • 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
  • SPL UNCLASSIFIED SECTION

    Other Information

    • Store at 20°C to 25°C (68°F to 77°C)
    • Lot No. & Exp. Date: see crimp of tube
  • INACTIVE INGREDIENT

    Inactive Ingredients

    cocoa butter, cotton seed oil, olive oil,  sodium pyruvate, vitamin E, white petrolatum, hard parrafin, mineral oil

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    Triple Antibiotic First Aid Antibiotic Ointment

    NET WT 0.5 OZ (14 g)

    label

  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC FIRST AID ANTIBIOTIC 
    bacitracin zinc, neomycin and polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-056
    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
    COCOA BUTTER (UNII: 512OYT1CRR)  
    COTTONSEED OIL (UNII: H3E878020N)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    SODIUM PYRUVATE (UNII: POD38AIF08)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52000-056-021 in 1 BOX12/09/2020
    114 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00412/09/2020
    Labeler - Universal Distribution Center LLC (019180459)
    Registrant - Savvy Care & Cosmetics Pvt. Ltd. (915039748)
    Establishment
    NameAddressID/FEIBusiness Operations
    Savvy Care 7 Cosmetics Pvt. Ltd.915039748manufacture(52000-056)
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