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 May 17, 2020

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  • Active Ingredient

    Ethyl Alchol v/v - 70%

  • Purposes

    Antiseptic

  • Uses

    Hand sanitizer to derease virus and bacteria on the skin that could cause disease. For when water and soap are not available

    Recommended for repeated use

  • Warnings

    For external use only: hands

    Flammable, keep away from fire or flame

  • When using this product

    keep out eyes, ears and mouth. 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 eyes, ears and mouth. Do not use in or near the eyes.

    In case of contact 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

    Conditions persists for more than 72 hours

  • Keep out of reach of children

    If swallowed, get medical help or contact a posion control center right away

  • Directions

  • Other information

    Sotre below 105 F (40C)

    May discolor certain fabrics

    Harmful to wood finishes and plastics

  • Inactive ingredients

    Purified water (Aqua), Isopropyl alcohol, Ozonized vegetable glycerin and carboxymethul cellulose

  • PRINCIPAL DISPLAY PANEL

    label 1000 ml 70% alcohol

    Maximun moisturizing formula

    Hand sanitizer

    kills 99.9% of germs

    topical, non steril solution

    33.81fl oz/ 1000 ml

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77210-0003
    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
    ISOPROPYL ALCOHOL (UNII: ND2M416302) 5 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX) 3.17 mL  in 100 mL
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) 5 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77210-0003-11000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/17/2020
    Labeler - EXPORTADORA IN & OUT S DE RL DE CV (951577298)
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