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 August 18, 2020

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  • ACTIVE INGREDIENT

    Ethyl Alcohol 62% w/w

  • INACTIVE INGREDIENT

    Water, Butylene Glycol, Glycerin, Carbomer, Triethanolamine, Sodium Hyaluronate, Camellia Sinensis Leaf Extract, Artemisia Princeps Extract

  • PURPOSE

    Antiseptic

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF THE CHILDREN

  • INDICATIONS & USAGE

    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.

  • 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

    For external use only

  • PRINCIPAL DISPLAY PANEL

    11

  • INGREDIENTS AND APPEARANCE
    FRESH WATER HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74773-0015
    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
    ARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74773-0015-1100 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/01/2020
    Labeler - THESKINFACTORY Co., Ltd. (694804099)
    Registrant - THESKINFACTORY Co., Ltd. (694804099)
    Establishment
    NameAddressID/FEIBusiness Operations
    WHAIN COSMETIC557837595manufacture(74773-0015)
    Establishment
    NameAddressID/FEIBusiness Operations
    THESKINFACTORY Co., Ltd.694804099label(74773-0015)
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