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 June 8, 2015

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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.

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  • PURPOSE

    PURPOSE: First aid antibiotic

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  • INDICATIONS & USAGE

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

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  • 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

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  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF THE REACH OF CHILDREN

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  • 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.

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  • INACTIVE INGREDIENT

    INACTIVE INGREDIENT: WHITE PETROLATUM

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  • INGREDIENTS AND APPEARANCE
    SCHEIN TRIPLE ANTIBIOTIC  
    neomycin sulfate, polymyxin b sulfate, bacitracin zinc ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0404-0360
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NEOMYCIN sulfate (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 3.5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 5000 [iU]  in 1 g
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 400 [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:0404-0360-47 144 in 1 BOX 04/21/2015
    1 NDC:0404-0360-09 0.9 g in 1 PACKET; Type 0: Not a Combination Product
    2 NDC:0404-0360-48 1 in 1 CARTON 04/21/2015
    2 NDC:0404-0360-28 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 04/21/2015
    Labeler - Henry Schein, Inc. (012430880)
    Registrant - Ultraseal Corporation (085752004)
    Establishment
    Name Address ID/FEI Business Operations
    ULTRAtab Laboratories, Inc. 085752004 manufacture(0404-0360)
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