Label: FRESH WATER HAND SANITIZER- 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 May 7, 2020

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  • ACTIVE INGREDIENT

    Ethyl Alcohol (Alcohol) 62% (w/w)

  • INACTIVE INGREDIENT

    Glycerin, Carbomer, Green Tea Extract, Aloe Extract, L-Menthol, Aminomethyl Propanol, Water

  • PURPOSE

    Antimicrobial

    Hand gel for cleaning and moisturizing the hand

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF THE CHILDREN

  • INDICATIONS & USAGE

    Store under 30°C (86°F)

  • WARNINGS

    For external use only.

    Flammable, keep away from fire or flame.

    When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.

    Stop use and ask a doctor if significant irritation or sensitization develops.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    • Put enough product in your palm to thoroughly cover your hands
    • Rub hands together briskly until dry
    • Children under 6 years of age should be supervised when using this product
  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    FRESH WATER HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74773-0013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    ALOE (UNII: V5VD430YW9)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74773-0013-162 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/01/2020
    Labeler - THESKINFACTORY Co., Ltd. (694804099)
    Registrant - THESKINFACTORY Co., Ltd. (694804099)
    Establishment
    NameAddressID/FEIBusiness Operations
    Soleo Cosmetic Co., Ltd.557829412manufacture(74773-0013)
    Establishment
    NameAddressID/FEIBusiness Operations
    THESKINFACTORY Co., Ltd.694804099label(74773-0013)
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