Label: HAND SANITIZER- alcohol gel

  • 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 September 23, 2020

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  • Active Ingredients

    Ethyl alcohol 70% v/v

  • Purpose

    Antiseptic

  • Uses

    Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available

  • Warnings

    For external use only . flammable - keep away from heat or flame

  • Do not use

    In children less than 2 months of age - on open skin wounds

  • When using this product

    keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes throrugly with water

  • Stop use and ask a doctor

    if irritation or rash occurs. These maybe signs of a serious condition.

  • keep out of reach of children

    if swallowed, get medical help or contact a poison control center right away.

  • Directions

    Put enough product on hands to cover all surfaces. Rub hands together until dry.

    Supervise children under 6 years of age when using this product to avoid swallowing

  • Other information

    Store between 15-30C (58-86F)

    Avoid freezing and excesive heat above 40C (104F)

  • Inactive ingredients

    Water (aqua), Vegetable Glycerine UPC, Hudroxypropyl methylcellulose and carboxymethylcellulose.

  • Principal Display

    Hand sanitizer

    70% alcohol

    68 fl. oz. (2.1qt) (2L) label 2000 ml

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80535-0002
    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
    WATER (UNII: 059QF0KO0R)  
    HYPROMELLOSE 2208 (60000 MPA.S) (UNII: 2F7T07H9ZD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80535-0002-12000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/23/2020
    Labeler - FARMACIA SAN ARCANGEL, S.A DE C.V (951583068)
    Registrant - FARMACIA SAN ARCANGEL, S.A DE C.V (951583068)
    Establishment
    NameAddressID/FEIBusiness Operations
    FARMACIA SAN ARCANGEL S.A DE C.V951583068manufacture(80535-0002) , label(80535-0002) , pack(80535-0002)
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