Label: CLEAN HANDS WASH WITHOUT WATER- alcohol gel

  • 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 July 29, 2020

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  • ACTIVE INGREDIENT

    Active ingredient

    Ethyl alcohol 85%

  • DOSAGE & ADMINISTRATION

    • PRESS OPEN on top of the tip-lid. 
    • Turn the bottle upside down. 
    • Squeeze out the gel in your hand. Rub it into your skin until dry. 
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Purpose

    Antiseptic.

  • Use

    Handsanitizer gel eliminates viruses and bacteria instantly, for use when soap and water not available.

  • Warnings

    For external use only.Flammable.
    Keep away from heat or flame.

    Do not use

    • On children less than 2 months of age.
    • On open skin wounds.

    When using this product

    • Keep out of eyes, ears, and mouth.
    • in case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor

    • if irritation or rash occurs.
    • These may be signs of a serious condition.
  • keep out of reach of children

    • Keep out of reach of children.
    • If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
  • Inactive Ingredients.

    Water,Hydroxypropylcellulose,Glycerin

  • Other Information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C ( 104F)
  • Product Label

    image description

  • INGREDIENTS AND APPEARANCE
    CLEAN HANDS WASH WITHOUT WATER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79908-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL85 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79908-009-0190 mL in 1 CONTAINER; Type 0: Not a Combination Product07/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/15/2020
    Labeler - PIERRE BEAUVAIS A/S (309510118)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pierre Beauvais A/S309510118manufacture(79908-009)
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