ULTRA SEAL TRIPLE ANTIBIOTIC (NEOMYCIN, POLYMIXIN, BACITRACIN) OINTMENT [ULTRA SEAL CORPORATION]

ULTRA SEAL TRIPLE ANTIBIOTIC (NEOMYCIN, POLYMIXIN, BACITRACIN) OINTMENT [ULTRA SEAL CORPORATION]
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NDC 42213-360-09, 42213-360-28, 42213-360-80
Set ID c6dc6040-12c2-44a5-bb1d-b67bc812b298
Category HUMAN OTC DRUG LABEL
Packager Ultra Seal Corporation
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
  • ACTIVE INGREDIENT

    Actve Ingredients: In each gram-Neomycin Sulfate-5 mg (equivalent to 3.5 mg Neomycin), Polymixin 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 IN THE 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 DEVELOPS

    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

    USC Triple tube carton

  • INGREDIENTS AND APPEARANCE
    ULTRA SEAL TRIPLE ANTIBIOTIC 
    neomycin, polymixin, bacitracin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42213-360
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE5 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:42213-360-80144 in 1 BOX09/05/2019
    1NDC:42213-360-090.9 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:42213-360-281 in 1 CARTON09/05/2019
    228 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B04/12/2011
    Labeler - Ultra Seal Corporation (085752004)
    Registrant - ULTRAtab Laboratories, Inc. (151051757)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultra Seal Corporation085752004pack(42213-360)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULTRAtab Laboratories, Inc.151051757manufacture(42213-360)

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