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 March 20, 2023

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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.

  • 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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