Label: CELLSKIN THE CLEAN HAND SANITIZER- alcohol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated June 1, 2020

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  • ACTIVE INGREDIENT

    ALCOHOL 62%

  • INACTIVE INGREDIENTS

    Water, Glycerin, Carbomer, Propylene Glycol, Triethanolamine, Menthol, Camellia Sinensis Leaf Extract, Citrus Paradisi (Grapefruit) Fruit Extract,
    Dimethicone, Tocopheryl Acetate, CI 42053

  • PURPOSE

    SANITIZER

  • WARNINGS

    For external use only. Flammable. Keep away from heat or flame
    --------------------------------------------------------------------------------------------------------
    Do not use
    • in 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

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

  • Uses

    Hand sanitizer to help reduce bacteria that potentially can cause disease.

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.

  • Other information

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

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    CELLSKIN THE CLEAN HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71080-0018
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.93 g  in 1.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Menthol (UNII: L7T10EIP3A)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    GRAPEFRUIT (UNII: O82C39RR8C)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71080-0018-220 in 1 CARTON05/01/2020
    1NDC:71080-0018-11.5 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/01/2020
    Labeler - GTG Wellness Co., Ltd. (689458057)
    Registrant - GTG Wellness Co., Ltd. (689458057)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natural Korea Co., Ltd.688729438manufacture(71080-0018)
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