Label: AEROSOOTHE- triple antibiotic ointment ointment

  • NDC Code(s): 55305-123-01, 55305-123-02, 55305-123-03
  • Packager: Aero Healthcare US LLC
  • 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 September 12, 2017

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  • 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.

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  • PURPOSE
  • WARNINGS
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

    IF INGESTED, CONTACT A POISON CONTROL CENTER RIGHT AWAY.

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  • DIRECTIONS

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

    INACTIVE INGREDIENT: WHITE PETROLATUM

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  • Indications & Usage

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

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  • AST05USV1
  • INGREDIENTS AND APPEARANCE
    AEROSOOTHE 
    triple antibiotic ointment ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55305-123
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    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
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55305-123-02 25 in 1 BOX 02/01/2016
    1 NDC:55305-123-01 0.9 g in 1 PACKET; Type 0: Not a Combination Product
    2 NDC:55305-123-03 0.5 g in 1 PACKET; Type 0: Not a Combination Product 10/20/2015
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 10/20/2015
    Labeler - Aero Healthcare US LLC (008186174)
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