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

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 January 3, 2023

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  • ACTIVE INGREDIENT

    In Each Gram-Bacitracin Zinc 500 units

  • ACTIVE INGREDIENT

    In Each Gram-Bacitracin Zinc 500 units

  • PURPOSE

    Purpose: First Aid Antibiotic

  • INDICATIONS & USAGE

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

  • 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.



  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children

  • 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.

  • INACTIVE INGREDIENT

    inactive Ingredient: White Petrolatum

  • PRINCIPAL DISPLAY PANEL

    hsBacitracinpacketcarton

  • INGREDIENTS AND APPEARANCE
    SCHEIN BACITRACIN 
    bacitracin zinc ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0404-0400
    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
    PETROLATUM (UNII: 4T6H12BN9U)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0404-0400-47144 in 1 CARTON12/04/2011
    1NDC:0404-0400-090.9 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:0404-0400-481 in 1 CARTON12/04/2011
    2NDC:0404-0400-2828 g in 1 TUBE; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00412/04/201101/01/2024
    Labeler - Henry Schein, Inc. (012430880)
    Registrant - ULTRAtab Laboratories, Inc. (151051757)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultra Seal Corporation085752004pack(0404-0400)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULTRAtab Laboratories, Inc.151051757manufacture(0404-0400)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultra Seal Corporation944090448pack(0404-0400)
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