AEROSOOTHE (TRIPLE ANTIBIOTIC OINTMENT) OINTMENT [AERO HEALTHCARE US LLC]

AEROSOOTHE (TRIPLE ANTIBIOTIC OINTMENT) OINTMENT [AERO HEALTHCARE US LLC]
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NDC 55305-123-01, 55305-123-02, 55305-123-03
Set ID 2287a31c-750c-728d-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Aero Healthcare US LLC
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
  • ACTIVE INGREDIENT

    Active 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

    First Aid Antibiotic

  • Warnings:

    For external use only.

    Do not use:

    • in eyes
    • over large areas of the body or on puncture wounds, animal bites or serious burns
    • for more than 1 week unless directed by a doctor
    • if you are allergic to any of the ingredients due to anaphylactic shock
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

    IF INGESTED, CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • DIRECTIONS

    • CLEAN AFFECTED AREA
    • APPPLY A SMALL AMOUNT 1 TO 3 TIMES DAILY
    • MAY COVER WITH A STERILE BANDAGE
  • INACTIVE INGREDIENT

    INACTIVE INGREDIENT: WHITE PETROLATUM

  • Indications & Usage

    FIRST AID TO HELP PREVENT INFECTION IN MINOR SCRAPES, CUTS AND BURNS.

  • AST05USV2

    ASTA05US.POU

  • INGREDIENTS AND APPEARANCE
    AEROSOOTHE 
    triple antibiotic ointment ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55305-123
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55305-123-0225 in 1 BOX02/01/2016
    1NDC:55305-123-010.9 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:55305-123-030.5 g in 1 PACKET; Type 0: Not a Combination Product10/20/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B10/20/2015
    Labeler - Aero Healthcare US LLC (008186174)

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