Label: KOI HAND SANITIZER- ethyl alcohol, 62% 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

    Ethyl Alcohol 62%...... Antimicrobial

    Antimicrobial

  • INDICATIONS & USAGE

    Hand sanitizer to help decrease bacteria on the skin. Recommended for repeat use.

  • WARNINGS

    For external use only. Flammable, keep away from fire or flames.

  • DO NOT USE

    Do not use in eyes. In case of contact, rinse thoroughly with water.

  • STOP USE

    Stop use and consult a doctor if irritation and redness develop and persist for more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Wet hands thoroughly with product and allow to dry without wiping. For children under 6, use only under adult supervision. Not recommended for infants.

  • STORAGE AND HANDLING

    Do not store about 110°F. Harmful to wood finishes and plastics.

  • INACTIVE INGREDIENT

    Deionized Water, Glycerin, Propylene Glycol, Organic Aloe Barbadensis (Aloe Vera) Leaf Extract, Panthenol (Pro-Vitamin B5), Tocopheryl Acetate (Vitamin E Acetate), Carbomer, Aminomethyl Propanol, Fragrance.

  • PRINCIPAL DISPLAY PANEL

    59 mL NDC: 73842-002-01

    2 oz sanitizer

  • INGREDIENTS AND APPEARANCE
    KOI HAND SANITIZER 
    ethyl alcohol, 62% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73842-002
    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
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73842-002-0159 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/13/2020
    Labeler - Koi CBD LLC (072518336)
    Registrant - Brad Ridenour (072518336)
    Establishment
    NameAddressID/FEIBusiness Operations
    Koi CBD LLC072518336manufacture(73842-002)
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