Label: SCHEIN BACITRACIN- bacitracin zinc ointment

  • NDC Code(s): 0404-0400-09, 0404-0400-28, 0404-0400-47, 0404-0400-48
  • Packager: Henry Schein, Inc.
  • 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 4, 2015

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    In Each Gram-Bacitracin Zinc 500 units

    Close
  • ACTIVE INGREDIENT

    In Each Gram-Bacitracin Zinc 500 units

    Close
  • PURPOSE

    Purpose: First Aid Antibiotic

    Close
  • INDICATIONS & USAGE

     First Aid to help prevent infection in minor cuts, burns, scrapes

    Close
  • WARNINGS

    DO NOT USE:  In the eyes.  Over large areas 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.

    Stop use and ask a doctor before use: in the case of dep puncture wounds, animal bites, or serious burns.  If the condition persists or gets worse. If a rash or other allergic reaction develops.

    If swallowed get medical help or contact a Poison Control Center immediately.



    Close
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children

    Close
  • DOSAGE & ADMINISTRATION

     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 1-3 times daily

    May be covered with a sterile bandage.

    Close
  • INACTIVE INGREDIENT

    inactive Ingredient: White Petrolatum

    Close
  • INGREDIENTS AND APPEARANCE
    SCHEIN BACITRACIN 
    bacitracin zinc ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0404-0400
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 500 [iU]  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0404-0400-47 144 in 1 CARTON
    1 NDC:0404-0400-09 .9 g in 1 PACKET; Type 0: Not a Combination Product
    2 NDC:0404-0400-48 1 in 1 CARTON
    2 NDC:0404-0400-28 28 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 12/04/2011
    Labeler - Henry Schein, Inc. (012430880)
    Registrant - ULTRAtab Laboratories, Inc. (151051757)
    Establishment
    Name Address ID/FEI Business Operations
    ULTRAtab Laboratories, Inc. 151051757 manufacture(0404-0400)
    Close