Label: HAND SANITIZER- ethyl alcohol gel

  • NDC Code(s): 43473-223-01
  • Packager: Nantong Health & Beyond Hygienic Products Inc.
  • Category: HUMAN OTC DRUG LABEL

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

    For hand washing to decrease bacteria on the skin.

    Recommended for repeated use.

  • WARNINGS

    Warnings

    Flammable. Keep away from fire or flame.

    For external use only.

    Avoid contact with broken skin.

  • WHEN USING

    When using this product do not use in or near the eyes.In case of contact, rinse eyes thoroughly with

    water.

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions

    Not recommended for infants.

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

    Children under 6 years of age should be supervised when using this product.

  • STORAGE AND HANDLING

    Other Information

    Do not store above 110°F. May discolor some fabrics.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, Aloe Barbadensis Leaf Juice, Maltodextrin,Glycerin, Propylene Glycol, Acrylates/C1O-30 Alkyl Acrylate crosspolymer, Triethanoamine, Fragrance, Tocopheryl Acetate.

  • PRINCIPAL DISPLAY PANEL

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43473-223
    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
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43473-223-01236 mL in 1 BOTTLE; Type 0: Not a Combination Product03/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/23/2020
    Labeler - Nantong Health & Beyond Hygienic Products Inc. (421280161)
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