Label: DEVOBIS 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 August 16, 2020

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  • Drug Facts

  • Active Ingredient

    Ethyl Alcohol 80%(v/v)

    Purpose

    Antiseptic

  • Use:

    • Hand sanitizer to help decrease bacteria on the skin
    • Recommended for repeat use
  • Warnings:

    For external use only
    Flammable, keep away from fire and flames

    Do not use

    in the eyes, In case of contact, rinse eyes thoroughly with water 

    Stop use and ask a doctor if

    • Irritation and redness develop
    • Condition persist for more than 72 hours

    Keep out of reach of children

    If swallowed, seek medical attention immediately or contact a Poison Contrl Center. Children must only use this product under adult supervision.

  • Directions:

    Place small amount of sanitizer in your palm. Thoroughly spread on both hands and rub together until dry.

  • Other information:

    Store below 110 °F

  • Inactive Ingredients:

    Aqua (Water), Glycerin, Acrylates/C 10-30 Alkyl Acrylate Crosspolymer, Hydrogen Peroxide, Aminomethyl Propanol.

  • Package Labeling:

    Box

  • INGREDIENTS AND APPEARANCE
    DEVOBIS HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:90030-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.8 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:90030-001-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/01/2020
    Labeler - ERTE KOZMETIK SANAYI VE TICARET ANONIM SIRKETI (354723129)
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