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 May 14, 2014

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  • ACTIVE INGREDIENT

    Active ingredient                         Purpose
    Bacitracin Zinc 500 Units                Antibiotic

  • Warnings:

    For external use only

    Dosage & Administration

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

    Indications & Usage

    • if you are allergic to any of the ingredients
    • in the eyes
    • over large areas of the body
    • longer than 1 week unless directed by a doctor

    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

  • Purpose:

    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
    • serious burns

  • Other information

    • store at controlled room temperature 15°-30° C (59°-86° F)
  • Stop Use and ask a doctor if

    • the condition persists or gets worse, or if a rash or other allergic reaction develops.
  • Inactive ingredients

    Hard Paraffin, Liquid Paraffin, White Soft Paraffin

  • Principal Display Panel

    Blossom Pharmaceuticals Bacitracin Zinc Ointment:

    bacitracin zinc.jpg

    Bacitracin Zinc Ointment


  • INGREDIENTS AND APPEARANCE
    BACITRACIN ZINC 
    bacitracin zinc ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61767-220
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61767-220-0228.35 g in 1 TUBE
    2NDC:61767-220-0314.17 g in 1 TUBE
    3NDC:61767-220-04113.4 g in 1 TUBE
    4NDC:61767-220-07425.3 g in 1 JAR
    5NDC:61767-220-050.5 g in 1 PACKET
    6NDC:61767-220-010.9 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B05/14/2014
    Labeler - Blossom Pharmaceuticals (677381470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blossom Pharmaceuticals677381470manufacture(61767-220)
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