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 March 24, 2018

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  • ACTIVE INGREDIENT

    Active Ingredient:
    Ethyl Alcohol 62% V/V

  • PURPOSE

    Purpose

    Antiseptic

  • WARNINGS

    Warnings

    For external use only.

    Flammable. Keep away from fire or flame.

  • STOP USE

    Stop use and ask a doctor if irritation or rash appears and lasts.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions

    Pump as needed into your palms to cover hands. Rub hands together brisky unitl dry. Children under 6 years old should be supervised when using this product.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, Aloe Barbadensis Leaf Juice, Maltodextrin, Glycerin, Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate, Crosspolymer, Triethanoamine, Fragrance, Tocopheryl Acetate, PPG-30 Cetyl Ether, PEG-40 Hydrogenated Castor Oil

  • OTHER SAFETY INFORMATION

    Other Information Store below 118 F.

  • INDICATIONS & USAGE

    Uses

    To help reduce bacteria on the skin.

  • PRINCIPAL DISPLAY PANEL

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72180-001
    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
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PPG-30 CETYL ETHER (UNII: 00C2W8NVII)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72180-001-0129 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/25/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/25/2018
    Labeler - Novelty Creative Solutions, Inc. (036326587)
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