Label: AEROWIPE- anstiseptic wipe swab

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 April 29, 2022

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  • Active Ingredient

    Benzalkonium Chloride, 0.13%

  • Purpose

    First Aid Antiseptic

  • USE

    To prevent infection in minor cuts, scrapes and burns

  • Warnings:

    For external use only

  • Do not use:

    • For deep puncture wounds, animal bites, or serious burns
    • In eyes or over large area of the body
  • Stop use and ask a doctor if:

    • Irritation, redness, or symptoms develop
    • the condition persists or gets worse
  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions:

    Tear pouch and clean the affected area.

  • Inactive Ingredient

    Purified Water

  • Package Label

    AW8001 Package

  • INGREDIENTS AND APPEARANCE
    AEROWIPE 
    anstiseptic wipe swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55305-118
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55305-118-101.5 g in 1 POUCH; Type 0: Not a Combination Product01/01/2016
    2NDC:55305-118-1225 in 1 BOX01/01/2016
    20.1 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2016
    Labeler - Aero Healthcare (008186174)