BACITRACIN (BACITRACIN) OINTMENT [G&W LABORATORIES, INC.]

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BACITRACIN (BACITRACIN) OINTMENT [G&W LABORATORIES, INC.]
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NDC 0713-0280-31
Set ID 630e0841-baf2-e9fa-b309-ad1a5f95da3b
Category HUMAN OTC DRUG LABEL
Packager Cosette Pharmaceuticals, Inc.
Generic Name
Product Class
Product Number
Application Number PART333B
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  • ACTIVE INGREDIENT

    Bacitracin 500 units

  • PURPOSE

    First aid antibiotic

  • USES

    first aid to help prevent infection in minor cuts, scrapes and burns

  • WARNINGS

    For external use only
    Do not use
    • if you are allergic to any of the ingredients
    • in the eyes
    • over large areas of the body
    • longer than 1 week unless directed by a doctor

    Ask a doctor before use in case of deep or puncture wounds, animal bites, or serious burns

    Stop use and ask a doctor if
    • the condition persists or gets worse
    • a rash or other allergic reaction develops

  • 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

  • INACTIVE INGREDIENT

    light mineral oil, white petrolatum

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Cosette Pharmaceuticals, Inc.

    Bacitracin Ointment
    FIRST AID ANTIBIOTIC
    Net Wt. 1 oz (28.4 g)

    unit-carton

  • INGREDIENTS AND APPEARANCE
    BACITRACIN  
    bacitracin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0713-0280
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0713-0280-3128.4 g in 1 TUBE; Type 0: Not a Combination Product01/10/1995
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B01/10/1995
    Labeler - Cosette Pharmaceuticals, Inc. (116918230)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosette Pharmaceuticals NC Laboratories, LLC079419931analysis(0713-0280) , label(0713-0280) , manufacture(0713-0280) , pack(0713-0280)
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