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 May 15, 2015

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  • ACTIVE INGREDIENT

    Active Ingredient:
    Ethyl Alcohol 62%

  • PURPOSE

    Purpose:
    Antiseptic

  • WARNINGS

    Warnings:
    Flammable. Keep away from fire or flame. For external use only. Avoid contact with broken skin.

  • 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.

  • INACTIVE INGREDIENT

    Water, Glycerin,Propylene Glycol, Carbomer, Triethanolamine, Aloe barbadenis Leaf Juice, Fragrance

  • STORAGE AND HANDLING

    Other Information:
    Do not store above 110 F. May discolor some fabrics.

  • INDICATIONS & USAGE

    For hand washing to decrease bacteria on the skin. Recommended for repeated use.

  • WHEN USING

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

  • PRINCIPAL DISPLAY PANEL

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69831-0001
    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
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69831-0001-129 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/15/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/15/2015
    Labeler - Laser Graphics Inc. (800758591)
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