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 June 16, 2020

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  • Active Ingredient

    Ethyl alcohol 63%

  • Purpose

    Antimicrobial

  • Use

    Hand sanitizer to help reduce bacteria on the skin that could cause disease.

    Recommended for repeated use.

  • Warnings

    Flammable. Keep away from fire or flame.

    For external use only - do not use on damaged or broken skin

  • When using this product

    keep out of eyes, ears, and mouth. in case of contact, rinse eyes thoroughly with water. avoid contact with broken skin. do not inhale or ingest

  • Stop use and ask a doctor

    if irritation or rash occurs and lasts.

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Other information

    Store below 86F (30C). avoid freezing and excessive heat 104F (40C). may discolor certain fabrics or surfaces.

  • Inactive ingredients

    water/eau, glycerin, acrylates/c10-30 alkyl acrylate crosspolymer, sodium hyaluronate, aminomethyl propanol, trehalose, biosaccharide gum-1, glycereth-26, tocopheryl acetate, flavor/aroma, red 40 (ci 16035), yellow 5 (ci 19140).

  • Directions

    place enough product on hands to cover hands thoroughly. rub hands together until dry. for children under 6 years of age, use only under adult supervision. not recommended for infants.

  • PRINCIPAL DISPLAY PANEL

    PDP

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12027-300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL63 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TREHALOSE (UNII: B8WCK70T7I)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERETH-26 (UNII: NNE56F2N14)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12027-300-0125 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/2020
    Labeler - Markwins Beauty Products, Inc. (135407760)
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