Label: HAND SANITIZER- ethyl alcohol gel

  • NDC Code(s): 72866-101-01
  • Packager: Merci Handy Corporation
  • 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 February 18, 2019

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  • ACTIVE INGREDIENT

    Active ingredient
    Alcohol 67%

  • PURPOSE

    Purpose
    Antiseptic

  • INDICATIONS & USAGE

    Uses

    for handwashing to decrease bacteria on the skin.

  • WARNINGS

    Warnings

    For external use only. Flammable, keep away from fire or flame.

    Do not use in the eyes.In case of contact, flush eyes with water.

  • STOP USE

    Stop use and ask a doctor if

    • irritation and redness develop.
    • condition persists for more than 72 hours
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    wet hand thoroughly with product and allow to dry without wiping

  • STORAGE AND HANDLING

    Other information

    store at a temperature below 110 F(43 C)

  • INACTIVE INGREDIENT

    Inactive ingredients

    water(aqua), aloe vera leaf juice, glycerin, propylene glycol, fragrance(parfum), acrylates/C30-10 alkyl acrylate crosspolymer, aminomethyl propanol, mannitol, microcrystalline cellulose, sucrose, corn(zea mays) starch, hydroxpropyl methyl cellulose, tocopheryl acetate, denatonium benzonate, maltodextrin, citral, geraniol, limonene, linalool, FD&C Blue No.1, FD&C Yellow No.5, Chromium Oxide Greens.

  • PRINCIPAL DISPLAY PANEL

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72866-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL67 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+)- (UNII: F4VNO44C09)  
    CITRAL (UNII: T7EU0O9VPP)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    GERANIOL (UNII: L837108USY)  
    CHROMIUM HYDROXIDE GREEN (UNII: RV8FT8XF5R)  
    MANNITOL (UNII: 3OWL53L36A)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SUCROSE (UNII: C151H8M554)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72866-101-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product02/18/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/18/2019
    Labeler - Merci Handy Corporation (116958007)
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