Label: RISUA HAND SANITIZER ETHANOL- 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 March 27, 2020

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  • Active Ingredients 

    Active ingredients: ALCOHOL 62.00%

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Water, Glycerin, Carbomer, Polysorbate 80, Triethanolamine

  • Purpose

    Purpose: SANITIZER

  • Warnings

    Warnings:

    Flammable. Keep away from fire or flame.
    For external use only
    Stop use and ask a doctor if irritation of redness develops and persist
    Keep out of reach of children
    In case of accidental digestion, seek professional assistance or contact a poison control center immediately

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. 

  • Uses

    Uses:

    To help remove bacteria and germs on the skin

  • Directions

    Directions:

    Please enough product in palm to cover hands and rub hands together briskly until dry.
    Not recommended for infants.

  • PACKAGE LABEL - RISUA HAND SANITIZER(ETHANOL) 500mL Bottle

    Image of bottle

  • PACKAGE LABEL - RISUA HAND SANITIZER(ETHANOL) 25mL Container

    Image of container

  • PACKAGE LABEL - RISUA HAND SANITIZER(ETHANOL) 1.5mL Pouch

    Image of pouch

  • INGREDIENTS AND APPEARANCE
    RISUA HAND SANITIZER ETHANOL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73758-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62.0 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73758-010-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/01/2020
    2NDC:73758-010-0225 mL in 1 CONTAINER; Type 0: Not a Combination Product03/01/2020
    3NDC:73758-010-031.5 mL in 1 POUCH; Type 0: Not a Combination Product03/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/01/2020
    Labeler - Dasol Co.,ltd. (557839013)
    Registrant - Dasol Co.,ltd. (557839013)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dasol Co.,ltd.557839013manufacture(73758-010)
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