Label: COSO HEALTH HAND SANITIZER GREEN TEA- ethyl 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 4, 2020

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  • ACTIVE INGREDIENT

    Ethyl alcohol 70%(w/w)

  • INACTIVE INGREDIENT

    Water, Carbomer, Aminomethyl Propanol, Jasminum Officinale (Jasmine) Extract, Prunus Mume Flower Extract, Bellis Perennis (Daisy) Flower Extract, Aloe Barbadensis Extract, Tocopheryl Acetate

  • PURPOSE

    ANTISEPTIC

  • WARNINGS

    ㆍFor external use only.
    ㆍFlammable. Keep away from fire or flame


    ㆍDo not use
    -in children less than 2 months of age
    -on open skin wounds


    ㆍWhen using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rins eyes thoroughly with water.


    ㆍStop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.


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

  • KEEP OUT OF REACH OF CHILDREN

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

  • Uses

    ㆍTo decrease bacteria on hands.

  • Directions

    ㆍPlease take out adequate amounts of gel on palm of your hand and rub your hands for 15 seconds at least.

  • Other Information

    ㆍStore between 15-30℃ (59-86℉)
    ㆍAvoid freezing and excessive heat above 40℃ (104℉)

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of bottle

  • INGREDIENTS AND APPEARANCE
    COSO HEALTH HAND SANITIZER  GREEN TEA
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75010-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) Alcohol350 g  in 500 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AminomethylPropanol (UNII: LU49E6626Q)  
    JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)  
    PRUNUS MUME FLOWER (UNII: 2N8872050J)  
    BELLIS PERENNIS FLOWER (UNII: 26I94X9A1K)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75010-100-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/01/2020
    Labeler - Mirfeel Korea Co., Ltd (695004258)
    Registrant - Mirfeel Korea Co., Ltd (695004258)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mirfeel Korea Co., Ltd695004258manufacture(75010-100)
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