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 July 23, 2014

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  • ACTIVE INGREDIENT

  • PURPOSE

  • INDICATIONS & USAGE

  • WARNINGS

  • INACTIVE INGREDIENT

  • KEEP OUT OF REACH OF CHILDREN

  • STORAGE AND HANDLING

  • DOSAGE & ADMINISTRATION

  • PRINCIPAL DISPLAY PANEL

    Bacitracin-0.9g

  • INGREDIENTS AND APPEARANCE
    BACITRACIN ZINC 
    bacitracin zinc ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-107
    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
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54162-107-090.9 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B07/23/2014
    Labeler - GERITREX CORP (112796248)
    Registrant - GERITREX CORP (112796248)
    Establishment
    NameAddressID/FEIBusiness Operations
    GERITREX CORP112796248manufacture(54162-107)
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