Label: CLEAR DEFENSE- 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 January 17, 2011

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  • ACTIVE INGREDIENT

    Active Ingredient
    Ethyl alcohol 62%

  • PURPOSE

    Purpose
    Antimicrobial

  • INDICATIONS & USAGE

    Uses

    • for handwashing to reduce bacteria on the skin
    • recommended for repeated use
  • WARNINGS

    Warnings
    For external use only
    Highly flammable. Keep away from fire or flame.

  • DO NOT USE

    Do not use in or near 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 or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • place enough product in your palm to thoroughly cover your hands
    • rub hands together briskly until dry
    • children under 6 years of age should be supervised when using this product
  • STORAGE AND HANDLING

    Other information

    • Store below 82°F (28°C)
  • PRECAUTIONS

    Other information

    • may discolor certain fabrics or surfaces
  • PRINCIPAL DISPLAY PANEL

    image of label

  • INACTIVE INGREDIENT

    Inactive ingredients
    water, glycerin, xylitol, anhydroxylitol, xylitylglucoside, carbomer, aminomethyl propanol, fragrance, aloe barbadensis leaf extract, melaleuca alternifolia leaf oil, polysorbate 20, tocopheryl acetate

  • INGREDIENTS AND APPEARANCE
    CLEAR DEFENSE 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-141
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL39.184 g  in 70 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    XYLITOL (UNII: VCQ006KQ1E)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Tea Tree Oil (UNII: VIF565UC2G)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54473-141-0370 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/09/2010
    Labeler - Melaleuca, Inc. (139760102)
    Establishment
    NameAddressID/FEIBusiness Operations
    Melaleuca, Inc.139760102manufacture
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