Label: 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 26, 2020

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  • Drug Facts

  • Active ingredient

    Ethyl alcohol 70%

    Purpose

    Antiseptic

  • Uses

    to decrease bacteria on the skin that could cause disease recommended for repeated use.

  • Warnings

    For external use only: hands

    Flammable, keep away from fire or flame

    When using this product 

    keep out of eyes, In case of contact with eyes, flush thoroughly with water./ avoid contact with broken skin/ do not inhale or ingest.

    Stop use and ask a doctor

    of irritation and redness develop/ condition persosts for more than 72 hours

    Keep out of reach of children

    if swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Wet hands thorouughly with product and allow to dry without wiping / for children under 6, use only under adult supervision/ not recommended for infacts

  • Other Information

    do not store above 105 F / may discolor some fabrics / harmful to wood finishes and plastics

  • Inactive Ingredients

    Water, glycerin/caprylate carbopol, vitamin E,Water, glycerin, caprate, tocopheryl acetate, acrylates/C10-30 alkyl acrylates crosspolymer

  • Package Labeling:240ml

    Bottle

  • Package Labeling:400ml

    Bottle2

  • Package Labeling:580ml

    Bottle3

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78153-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLOYL/CAPROYL METHYL GLUCAMIDE (UNII: 0451R360HR)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78153-000-08240 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
    2NDC:78153-000-13400 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
    3NDC:78153-000-19580 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/15/2020
    Labeler - Quimi Clean (951578018)
    Establishment
    NameAddressID/FEIBusiness Operations
    Quimi Clean951578018manufacture(78153-000)
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