Label: HAND SANITIZER- ethyl 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 April 21, 2020

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  • ACTIVE INGREDIENT

    Active Ingredient
    Ethyl Alcohol 62%

  • PURPOSE

    Purpose
    Antiseptic

  • INDICATIONS & USAGE

    Uses Decrease bacteria on hands

  • WARNINGS

    Warnings For external use only.

    Keep out of eyes. In case of contact with eyes, flush thoroughly with water.

  • KEEP OUT OF REACH OF CHILDREN

    Keep it out of reach of children.

  • STOP USE

    Stop use and ask a doctor if irritation or redness develop.If swallowed,get medical help or contact a doctor right away.

  • STORAGE AND HANDLING

    Storage: Flammable,Avoid direct sunlight and keep away from fire.

  • DOSAGE & ADMINISTRATION

    Directions: Wet hands thoroughly with product and allow to dry without wiping.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Aloe Barbadensis Leaf Juice, Glycerin, Propylene Glycol, Fragrance, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Maltodextrin, Aminomethyl Propanol, Lactose, Microcrystalline Cellulose, Sucrose, Zea Mays (corn) Starch, Tocopheryl Acetate, Hydroxypropyl Methyl Cellulose, Ultramarines (CI 77007), FD&C Red No.4 (CI 14700), D&C Red No.33 (CI 17200).

  • PRINCIPAL DISPLAY PANEL

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73950-052
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    ULTRAMARINE BLUE (UNII: I39WR998BI)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    .ALPHA.-LACTOSE (UNII: MJF4JAT10B)  
    SUCROSE (UNII: C151H8M554)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73950-052-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/17/2020
    Labeler - MINISO DEPOT CA, INC. (056958961)
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