Label: CLEAR DEFENSE HARVEST APPLE- 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 29, 2018

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  • Active ingredient

    Ethyl alcohol 62%

  • Purpose

    Antimicrobial

  • Uses

    ■ for handwashing to reduce bacteria on the skin

    ■ recommended for repeated use

  • WARNINGS

    Warnings: For external use only

  • 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) ■ may discolor certain fabrics or surfaces ■ alcohol derived from corn

  • INACTIVE INGREDIENT

    Inactive ingredients water, gylcerin, xylitol, anhydroxylitol, xylitylglucoside, carbomer, aminomethyl propanol, fragrance, aloe barbadensis leaf extract, melaleuca alternifolia leaf oil, polysorbate 20, tocopheryl acetate, jojoba esters, butyrospermum parkii, theobroma cacao seed butter, mangifera indica seed butter, blue 1 lake, titanium dioxide, yellow 5 lake

  • PRINCIPAL DISPLAY PANEL

    CD Harvest AppleCD Harvest Apple

  • INGREDIENTS AND APPEARANCE
    CLEAR DEFENSE  HARVEST APPLE
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-273
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL36.58 g  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ANHYDROXYLITOL (UNII: 8XWR7NN42F)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    WATER (UNII: 059QF0KO0R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54473-273-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/01/2016
    Labeler - Melaleuca Inc (139760102)
    Registrant - Melaleuca Inc (139760102)
    Establishment
    NameAddressID/FEIBusiness Operations
    Melaleuca Inc079711683manufacture(54473-273)
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