Label: PROVON FOAMING MEDICATED HANDWASH WITH MOISTURIZERS AND TRICLOSAN- triclosan liquid

  • NDC Code(s): 21749-096-20, 21749-096-53, 21749-096-89, 21749-096-90, view more
    21749-096-97
  • Packager: GOJO Industries, 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 December 17, 2018

If you are a consumer or patient please visit this version.

  • Active ingredient

    Triclosan 0.3%

    Close
  • Purpose

    Antimicrobial

    Close
  • Use

    • Handwash to help decrease bacteria on the skin before and after contact with a person under medical care or treatment
    • Recommended for repeated use
    Close
  • 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.

    Close
  • Directions

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

    Water (Aqua), Propylene Glycol, Alcohol, Lauric Acid, Ethanolamine, Disodium Cocoamphodiacetate, Lactic Acid, Isopropyl Alcohol, PEG-4, Polyquaternium-10, Sodium Metabisulfite, Sodium Sulfite, Tetrasodium EDTA, Sodium Sulfate, Fragrance (Parfum), Iodopropynyl Butylcarbamate, Green 3 (CI 42053)

    Close
  • INGREDIENTS AND APPEARANCE
    PROVON FOAMING MEDICATED HANDWASH WITH MOISTURIZERS AND TRICLOSAN 
    triclosan liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:21749-096
    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)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALCOHOL (UNII: 3K9958V90M)  
    LAURIC ACID (UNII: 1160N9NU9U)  
    MONOETHANOLAMINE (UNII: 5KV86114PT)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    POLYETHYLENE GLYCOL 200 (UNII: R95B8J264J)  
    POLYQUATERNIUM-10 (30000 MPA.S AT 2%) (UNII: C7RDC8Y4JS)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    SODIUM SULFITE (UNII: VTK01UQK3G)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:21749-096-89 1200 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/30/2009
    2 NDC:21749-096-90 1250 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/30/2009
    3 NDC:21749-096-97 700 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/30/2009
    4 NDC:21749-096-53 535 mL in 1 PACKAGE; Type 0: Not a Combination Product 11/30/2009
    5 NDC:21749-096-20 2000 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/30/2009
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 11/30/2009 12/01/2020
    Labeler - GOJO Industries, Inc. (004162038)
    Establishment
    Name Address ID/FEI Business Operations
    GOJO Industries, Inc. 036424534 manufacture(21749-096)
    Close