Label: HYDRATING HAND SAINTIZER- ethyl alcohol aerosol, foam

  • 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 November 24, 2020

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  • ACTIVE INGREDIENT

    Ethyl Alcohol 70%

  • PURPOSE

    Purpose -Antiseptic Skin cleanser 

  • INDICATIONS & USAGE

    Use

    • Antiseptic Skin cleanser
  • WARNINGS

    Warnings

    Keep away from open flame & sources of heat.

    For extenal use only.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of children

    If accidently swallowed, call a posion control center or get medical help right away.

  • USER SAFETY WARNINGS

    Do not get into eyes

    If contact occurs, rinse thoroughly with water

  • DOSAGE & ADMINISTRATION

    • Children,adolescents and adults 2 years and over.
    • for occasional and personal domestic use
    • supervise children when they use this product.
    • Place enough product on your plam to thoroughly cover your hands.
    • rub thoroughly into hands for at least 30 seconds
    • Allow to dry.
  • OTHER SAFETY INFORMATION

    Other Information

    • May discolor certain fabrics or surfaces
    • do not store above 110 F ( 43 C)
  • INACTIVE INGREDIENT

    Distilled Water, Vegetable Glycerin, PEG 10 Dimethicone, Grapefruit Essential Oil Blend, Aloe Barbadensis Leaf Juice, Denatonium Benzoate.

  • PRINCIPAL DISPLAY PANEL

    111

    2

  • INGREDIENTS AND APPEARANCE
    HYDRATING HAND SAINTIZER 
    ethyl alcohol aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80382-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE PEG-10 PHOSPHATE (UNII: O7Q5NJ7X88)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GRAPEFRUIT OIL (UNII: YR377U58W9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80382-001-303780 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/20/2020
    Labeler - Natural Distributions Ltd. o/a Purple Frog Products Suite (204124481)
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