Label: CLEAN ON HAND SANITIZER- alcohol 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 April 14, 2020

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  • ACTIVE INGREDIENT

    Active ingredients: Alcohol 62.0% w/w

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Water, Carbomer, Triethanolamine, Glycerin, Propylene Glycol, Sodium Hyaluronate, Phenoxyethanol, Panthenol, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Dipotassium Glycyrrhizate

  • PURPOSE

    PURPOSE: SANITIZER

  • WARNINGS

    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

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

  • Uses

    Uses

    Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

  • Directions

    Directions

    Take an appropriate amount on your hands and rub thoroughly to dry.
    Children under 6 years of age should be supervised when using this product.

  • Other Information

    Other Information

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

  • PACKAGE LABEL - CLEAN ON HAND SANITIZER GEL 3mL * 10ea

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  • PACKAGE LABEL - CLEAN ON HAND SANITIZER GEL 30mL

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  • PACKAGE LABEL - CLEAN ON HAND SANITIZER GEL 300mL

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  • INGREDIENTS AND APPEARANCE
    CLEAN ON HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74522-010
    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
    Water (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Glycerin (UNII: PDC6A3C0OX)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Panthenol (UNII: WV9CM0O67Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74522-010-0210 in 1 CARTON04/01/2020
    1NDC:74522-010-013 mL in 1 POUCH; Type 0: Not a Combination Product
    2NDC:74522-010-0330 mL in 1 CONTAINER; Type 0: Not a Combination Product04/01/2020
    3NDC:74522-010-04300 mL in 1 CONTAINER; Type 0: Not a Combination Product04/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/01/2020
    Labeler - Caolion Cosmetics Co., Ltd. (557792513)
    Registrant - Caolion Cosmetics Co., Ltd. (557792513)
    Establishment
    NameAddressID/FEIBusiness Operations
    KOREA COSPACK CO.,LTD.689059789manufacture(74522-010)
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