Label: CLEAR DEFENSE- ethyl alcohol gel

  • NDC Code(s): 54473-296-09, 54473-296-16, 54473-296-18, 54473-296-24
  • Packager: Melaleuca, Inc.
  • 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 11, 2023

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  • ACTIVE INGREDIENT

    Active ingredient
    Ethyl Alcohol 62%

  • PURPOSE

    Purpose
    Antimicrobial

  • INDICATIONS & USAGE

    Uses

    • 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

    • dispense a generous amount of gel in your palm
    • spread gel over your hands until thoroughly coated
    • rub your hands together briskly until dry
    • children under 6 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
  • INACTIVE INGREDIENT

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

  • PRINCIPAL DISPLAY PANEL

    image of label

  • INGREDIENTS AND APPEARANCE
    CLEAR DEFENSE 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-296
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL150.97 g  in 266 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XYLITOL (UNII: VCQ006KQ1E)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54473-296-09266 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2018
    2NDC:54473-296-2471 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2020
    3NDC:54473-296-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2020
    4NDC:54473-296-1853 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2020
    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.079711683manufacture(54473-296)
    Establishment
    NameAddressID/FEIBusiness Operations
    Melaleuca - TN805617610manufacture(54473-296)
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