Label: BACITRACIN ZINC 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 March 22, 2011

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  • ACTIVE INGREDIENT

    Active ingredient                   Purpose           
    Bacitracin Zinc 500 Units                Antibactrerial

  • Uses:

    First aid to help prevent infection in:
    • Minor cuts
    • scrapes
    • burns
  • Ask a doctor before use:

    • in case of deep or puncture wounds, animal bites and serious burns
    • if the condition persists or gets worse
    • if a rash or any other allergic reaction develops

  • Other information

    • store at controlled room temperature 15°-30° C (59°-86° F)
    • Tamper Evident. Do not use if packet is torn, cut or opened.
  • Inactive ingredients

    White Petrolatum

  • INDICATIONS & USAGE



    Indications and Usage

    • For first aid to help prevent infection in minor skin abrasions and rashes.
  • Directions:

    • clean the affected area
    • apply a small amount of this product (an amount equal to the surface area of the tip of the finger) on the area 1-3 times daily.
    • may be covered with a sterile bandage
  • 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.

  • WARNINGS

    • for external use only

       
  • Do not use:

    Do not use:

    • in the eyes
    • over large area 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
  • Principal Display Panel

    Principal Display Panel

    bacitracin_zinc

  • INGREDIENTS AND APPEARANCE
    BACITRACIN ZINC 
    bacitracin zinc ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-239
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN ZINC - UNII:89Y4M234ES) BACITRACIN ZINC500 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-239-0112 in 1 CASE
    1144 in 1 BOX
    10.9 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B12/01/2009
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)
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