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 7, 2020

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  • Active Ingredient

    Ethyl alcohol v/v- 60-80%

  • 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 form fire and flame

  • When using this product

    keep out of ayes, do not use in or near the 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 ayes, do not use in or near the 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 center right away

  • Directions

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

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

    not recommended for infants

  • Other information

    Store below 105 F 40C

    Mary discolour certain fabrics

    harmful to wood finishes and plastics

  • Inactive ingredients

    Purified water (aqua), vegetable glycerin, carboxymethyl cellulose, hydroxypropyl methylcellulose HPMC, and pepper mint oild and vitamine E

  • Principal display

    label 500 ml label 250 ml label 1000 ml Natural ingredients

    Mint

    Hand sanitizer gel

    eliminates 99.9% of germs

    vitamine E hands soft

    contain mosturizers

    *e coli and S. areus

    HO3

    parabens

    methanol

    formaldehyde

    triethanolamine

    carbopol

    free

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80535-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSE 2208 (60000 MPA.S) (UNII: 2F7T07H9ZD)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80535-0001-11000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/07/2020
    2NDC:80535-0001-2250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/07/2020
    3NDC:80535-0001-3500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/07/2020
    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.V.951583068label(80535-0001) , pack(80535-0001) , manufacture(80535-0001)
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