Label: BACITRACIN ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 9, 2012

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  • SPL UNCLASSIFIED SECTION

  • ACTIVE INGREDIENT

    Bacitracin 500 units per gram.

  • PURPOSE

    First aid antibiotic.

  • INDICATIONS

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

  • WARNINGS

    For external use only. Do not use in the eyes or apply over large areas of the body. In case of deep puncture wounds, animal bites, or serious burns, consult a doctor.

  • Stop use and consult a doctor 

    if the condition persists or gets worse, or if a rash or other allergic reaction develops. Do not use if you are allergic to any of the ingredients. Do not use longer than one week unless directed by a doctor.

  • KEEP OUT OF REACH OF CHILDREN.

  • DIRECTIONS

    After gentle washing, apply a small amount (an amount equal to the surface area of the tip of a finger) directly to the affected areas and cover with sterile gauze if desired. May be applied 1 to 3 times daily as the condition indicates.

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • Inactive ingredients 

    ALSO CONTAINS

    Mineral oil, white petrolatum

  • Storage

    Store in controlled room temperature 59°-88°F (15°-30°C).

  • PRINCIPAL DISPLAY PANEL

    NDC 54868-3269-1

    package label

    BACITRACIN OINTMENT U.S.P.

    First Aid Antibiotic

    NET WT. 1 OZ. (28.35g)



    DENISON PHARMACEUTICALS
    PAWTUCKET, RI   02862



    Additional barcode labeling by:
    Physicians Total Care, Inc.
    Tulsa, Oklahoma      74146

  • INGREDIENTS AND APPEARANCE
    BACITRACIN 
    bacitracin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-3269(NDC:0295-1223)
    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
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-3269-11 in 1 CARTON
    128.35 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333B08/22/1979
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel(54868-3269)
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