Label: SCHEIN TRIPLE ANTIBIOTIC- neomycin sulfate, polymyxin b sulfate, bacitracin zinc ointment

  • NDC Code(s): 0404-0360-09, 0404-0360-28, 0404-0360-47, 0404-0360-48
  • 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 October 29, 2019

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  • ACTIVE INGREDIENT

    Actve Ingredients: In each gram-Neomycin Sulfate-5 mg (equivalent to 3.5 mg Neomycin), Polymyxin B Sulfate-5000 I.U., Bacitracin Zinc-400 I.U.

  • PURPOSE

    PURPOSE: First aid antibiotic

  • INDICATIONS & USAGE

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

  • WARNINGS

    For external use only. Do not use on eyes. Do not use if you are allergic to any of the ingredients due to the possibility of anaphylactic shock.

    Stop use and ask a doctor before use in cases of deep puncture wounds, animal bites, serious burns; if the condition persists or gets worse; if a rash or other allergic reaction developes

    If swallowed get medical help or contact a poison control center right away

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF THE REACH OF CHILDREN

  • DOSAGE & ADMINISTRATION

    Clean the affected area. apply a small amount of 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

    Schein Triple carton

  • INGREDIENTS AND APPEARANCE
    SCHEIN TRIPLE ANTIBIOTIC 
    neomycin sulfate, polymyxin b sulfate, bacitracin zinc ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0404-0360
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0404-0360-47144 in 1 BOX04/21/2015
    1NDC:0404-0360-090.9 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:0404-0360-481 in 1 CARTON04/21/2015
    2NDC:0404-0360-2828 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B04/21/2015
    Labeler - Henry Schein, Inc. (012430880)
    Registrant - Ultraseal Corporation (085752004)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultra Seal Corporation085752004pack(0404-0360)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULTRAtab Laboratories, Inc.151051757manufacture(0404-0360)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultra Seal Corporation944090448pack(0404-0360)