Label: DURIDE 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 May 11, 2020

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  • ACTIVE INGREDIENT

    Alcohol

  • INACTIVE INGREDIENT

    Water(Aqua), Glycerin, Carbomer, Aloe Barbadensis Leaf Juice(Aloe Vera), Tocopheryl Acetate(Vitamin E), Phenoxyethanol, Aminomethyl propanol

  • PURPOSE

    Antimicrobial

  • INDICATIONS & USAGE

    ■ Hand sanitizer to help reduce bacteria on the skin.

  • WARNINGS

    ■ Flammable. Keep away from fire or flame.

    ■ For external use only.

  • DO NOT USE

    ■ in children less than 2 months of age
    ■ on open skin wounds

  • WHEN USING

    When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation or rash appears and lasts

  • 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.

  • STORAGE AND HANDLING

    Store below 110℉(43℃)

  • DOSAGE & ADMINISTRATION

    Pump 1-2 times and rub it into your hand. For topical use only.

  • PRINCIPAL DISPLAY PANEL

    Duride Hand Sanitizer Label

  • INGREDIENTS AND APPEARANCE
    DURIDE HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77498-210
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL210 mL  in 300 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77498-210-0160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/12/2020
    2NDC:77498-210-02250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/12/2020
    3NDC:77498-210-03300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/12/2020
    4NDC:77498-210-04500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/12/2020
    Labeler - Rainbow International Services Inc. (046587936)
    Registrant - Rainbow International Services Inc. (046587936)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rainbow International Services Inc.046587936label(77498-210)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Pinshang Biotechnology Development Co.,Ltd554530020manufacture(77498-210)
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