Label: AEROWIPE- alcohol 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 June 8, 2016

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  • Active Ingredient

  • Use:

    To help prevent infection in minor cuts and scrapes

  • Warnings:

    • For external use only
    • Flammable, keep away from fire or flame
  • Do not use:

    • Longer than 1 week
    • In the eyes
  • Stop Use:

    If irritation and redness develop. If condition persists consult your health care practitioner.

  • Keep out of reach of children.

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

  • Directions

    Apply topically to cleanse the intended area and discard after single use.

  • Inactive Ingredient

    Purified Water

  • Purpose

    Antiseptic

  • Package Label

    Principal Display PanelAEROWIPE Alcohol Wipe

    Saturated with 70% Isopropyl Alcohol.

    Code: AW7001

    1 Wipe

    Manufactured for Aero Healthcare

    AUS - Armidale NSW 2350

    UK - Horsham RH13 5QL

    US - Congers NY 10920

    www.aerohealthcare.com

    LOT XXXXX

    EXP XXXXXX

  • INGREDIENTS AND APPEARANCE
    AEROWIPE 
    alcohol wipe swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55305-120
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55305-120-010.4 mL in 1 POUCH; Type 0: Not a Combination Product01/01/2016
    2NDC:55305-120-0250 in 1 BOX01/01/2016
    20.4 mL in 1 POUCH; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2016
    Labeler - Aero Healthcare (008186174)
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