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 August 19, 2011

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  • Drug Facts

  • Active ingredients (in each gram)

    Bacitracin Zinc (equal to 500 bacitracin units)

  • Purpose

    Antibiotic

    Uses first aid to help prevent infection in minor cuts scrapes burns

    Warnings For External use only

    Do not use in the eyes over large areas of the body if you are allergic to any of the ingredients

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

    When using this product do not use longer than 1 week unless directed by a doctor

    Stop use and ask a doctor if the condition persists or gets worse if 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 white petrolatum

    E. FOUGERA and CO.
    a division of Nycomed US Inc.
    MELVILLE, NEW YORK 11747

    Repacked by:
    H.J. Harkins Company Inc.
    Nipomo, CA 93444
  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    BACITRACIN ZINC 
    bacitracin zinc ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52959-113(NDC:0168-0011)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin Zinc - UNII:89Y4M234ES) Bacitracin Zinc500 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52959-113-0328.34 g in 1 TUBE
    2NDC:52959-113-1514.17 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B01/08/2010
    Labeler - H.J. Harkins Company, Inc. (147681894)
    Registrant - Nycomed US Inc. (043838424)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nycomed US Inc.174491316MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Nycomed US Inc.043838424ANALYSIS, MANUFACTURE
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