Label: WELKEEPS WONDER CHECK HAND SANITIZER- ethanol gel

  • Category: HUMAN OTC DRUG LABEL

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 4, 2020

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  • ACTIVE INGREDIENT

    ETHANOL 70 % v/v

  • INACTIVE INGREDIENT

    Water, Glycerin, Propylene Glycol, Carbomer, Green Tea Extract, Aloe Vera Gel, Sodium Hyaluronate, Camomille Extract(1), Lemon Oil, Triethanolamine

  • PURPOSE

    ANTISEPTIC

  • 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 on the skin.

  • Directions

    • Put enough product in your palm to cover hands and rub hands together briskly until dry.
    • Children under 6 years of age should be supervised when using WELKEEPS WONDER CHECK HAND SANITIZER

  • Other Information

    • Store below 110℉ (43℃)
    • May discolor certain fabrics or surfaces

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of bottle

  • INGREDIENTS AND APPEARANCE
    WELKEEPS WONDER CHECK HAND SANITIZER 
    ethanol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78570-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) Alcohol350 mL  in 500 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CHAMOMILE (UNII: FGL3685T2X)  
    Lemon Oil (UNII: I9GRO824LL)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78570-010-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/01/2020
    Labeler - Welkeeps Co.,Ltd. (688465824)
    Registrant - Welkeeps Co.,Ltd. (688465824)
    Establishment
    NameAddressID/FEIBusiness Operations
    Korea Life Science Co.,ltd694914835manufacture(78570-010)