ULTRA SEAL BACITRACIN (BACITRACIN ZINC) OINTMENT [ULTRA SEAL CORPORATION]

ULTRA SEAL BACITRACIN (BACITRACIN ZINC) OINTMENT [ULTRA SEAL CORPORATION]
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NDC 42213-400-28
Set ID 94a6a149-cead-485b-bf88-273f5f74748d
Category HUMAN OTC DRUG LABEL
Packager Ultra Seal Corporation
Generic Name
Product Class
Product Number
Application Number PART333B
  • ACTIVE INGREDIENT

    In Each Gram-Bacitracin Zinc 500 units

  • PURPOSE

    Purpose: First Aid Antibiotic

  • INDICATIONS & USAGE

     First Aid to help prevent infection in minor cuts, burns, scrapes

  • WARNINGS

    DO NOT USE:  In the eyes.  Over large areas of the body. If you are allergic to any of the ingredients due to the possibility of anaphylactic shock. Longer than 1 week unless directed by a doctor.

    Stop use and ask a doctor before use: in the case of dep puncture wounds, animal bites, or serious burns.  If the condition persists or gets worse. If a rash or other allergic reaction develops.

    If swallowed get medical help or contact a Poison Control Center immediately.



  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children

  • DOSAGE & ADMINISTRATION

     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 1-3 times daily

    May be covered with a sterile bandage.

  • INACTIVE INGREDIENT

    inactive Ingredient: White Petrolatum

  • PRINCIPAL DISPLAY PANEL

    Bacitracin tube carton

  • INGREDIENTS AND APPEARANCE
    ULTRA SEAL BACITRACIN  
    bacitracin zinc ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42213-400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42213-400-281 in 1 CARTON12/04/2011
    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 finalpart333B12/04/2011
    Labeler - Ultra Seal Corporation (085752004)
    Registrant - ULTRAtab Laboratories, Inc. (151051757)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULTRAtab Laboratories, Inc.151051757manufacture(42213-400)

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