Label: TRICLOSAN- triclosan liquid

  • NDC Code(s): 21749-415-10, 21749-415-16, 21749-415-20
  • Packager: GOJO Industries, 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 October 14, 2016

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  • Active ingredient

    Triclosan 0.3%

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  • Purpose

    Antimicrobial

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  • Use

    • Handwash to help decrease bacteria on the skin
    • Recommended for repeated use
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  • Warnings

    For external use only

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

    Stop use and ask a doctor if irritation or rash appears and lasts

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    • Wet hands
    • Apply a small amount of product and work into a lather
    • Rinse well and dry hands completely
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  • Inactive ingredients

    Water (Aqua), Coconut Acid, Sodium Sulfate, Oleic Acid, Ethanolamine, Aloe Barbadensis Leaf Juice, Cocamide MEA, Coco-Betaine, Hydrolyzed Vegetable Protein, Propylene Glycol, Retinyl Palmitate, Tetrasodium EDTA, Tocopheryl Acetate, Zea Mays (Corn) Oil, Hydroxypropyl Methylcellulose, Methylchloroisothiazolinone, Methylisothiazolinone

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  • INGREDIENTS AND APPEARANCE
    TRICLOSAN 
    triclosan liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:21749-415
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 0.003 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    COCONUT ACID (UNII: 40U37V505D)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    OLEIC ACID (UNII: 2UMI9U37CP)  
    MONOETHANOLAMINE (UNII: 5KV86114PT)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    COCO-BETAINE (UNII: 03DH2IZ3FY)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CORN OIL (UNII: 8470G57WFM)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Methylchloroisothiazolinone (UNII: DEL7T5QRPN)  
    Methylisothiazolinone (UNII: 229D0E1QFA)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:21749-415-10 1000 mL in 1 BAG; Type 0: Not a Combination Product 03/10/2010
    2 NDC:21749-415-20 2000 mL in 1 BOX; Type 0: Not a Combination Product 03/10/2010
    3 NDC:21749-415-16 473 mL in 1 PACKAGE; Type 0: Not a Combination Product 03/10/2010
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 03/10/2010 12/01/2021
    Labeler - GOJO Industries, Inc. (004162038)
    Registrant - GOJO Industries, Inc. (004162038)
    Establishment
    Name Address ID/FEI Business Operations
    GOJO Industries, Inc. 036424534 manufacture(21749-415)
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