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 October 29, 2020

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  • Active Ingredient

    Alcohol v/v 70%

  • Purposes

    Antimicrobial

  • Uses

    Hand sanitizer to decrease bacteria on the skin that could cause disease

    Recommended for repetead use

  • Warnings

    for external use only: hands

    flammable, keep away from fire and flame

  • When using this product

    keep out of eyes, do not use in or near eyes.

    -in case of contact with eyes flush thorougly with water

    -avoid contact with broken skin

    -do not inhale or ingest

  • when using this product

    keep out of eyes, do not use in or near eyes.

    -in case of contact with eyes flush thorougly with water

    -avoid contact with broken skin

    -do not inhale or ingest

  • Stop use and ask a doctor if

    Irritation and redness develop

    Condition persists 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

    put enough product in your palm to cover hands and rub hands together briskly until dry without wiping

    for children uncer 6 years of age should be supervised when using

    not recommended for infants

  • Other information

    Store below 105 F (40 c)

    may discolour certain fabrics

    harmful to wood finishes and plastics

  • Inactive Ingredients

    Purified water (aqua), Vegetable glycerin, Hydroxipropyl methylcellulose, carboxymethyl cellulose

  • Principal Display

    label 20 L Hand sanitizer gel

    eliminates 99.9% of germs

    70% alcohol

    Natural ingredients hands soft

    Contains moisturizers

    640 fl oz/ 20 L

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80535-0004
    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)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    HYPROMELLOSE 2208 (60000 MPA.S) (UNII: 2F7T07H9ZD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80535-0004-120000 mL in 1 DRUM; Type 0: Not a Combination Product10/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/29/2020
    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.V951583068label(80535-0004) , manufacture(80535-0004) , pack(80535-0004)
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