Label: PROFORMANCE SERIES ANTIBACTERIAL- triclosan liquid

  • 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 3, 2011

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  • ACTIVE INGREDIENT

    Active ingredient

    Triclosan, 0.30%

  • PURPOSE

    Purpose

    Antibacterial

  • INDICATIONS & USAGE

    Uses

    For hand washing to reduce bacteria on the skin

  • WARNINGS

    Warnings

    For external use only

    When using this product avoid contact with the eyes.

    In case of eye contact, flush with water.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Enter section text here

  • DOSAGE & ADMINISTRATION

    Directions

    Apply foaming cleanser to dry hands

    Rub hands together to spread lather

    Wash for 15-20 seconds

    Rinse and dry hands thoroughly

  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, Sodium Laureth Sulfate, Propylene Glycol, PPG-24-Glycereth-24, Cocamidopropyl Betaine, Tetrasodium EDTA, 2-Bromo-2-nitropropane-1,3-diol, Fragrance, Citric Acid, Green 5 (CI 61570), Yellow 5 (CI 19140).

  • PRINCIPAL DISPLAY PANEL

    ProFormance Series

    Antibacterial Foam Soap

    Pro-Link

    MA1000

    Distributed exclusively by Pro-Link, Inc.

    1 Liter

    33.8 Fluid Ounces

    container label

  • INGREDIENTS AND APPEARANCE
    PROFORMANCE SERIES ANTIBACTERIAL  
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66908-053
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.30 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66908-053-271000 mL in 1 BOTTLE, PLASTIC
    2NDC:66908-053-121200 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2011
    Labeler - Pro-Link, Inc. (144650637)
    Registrant - Deb USA, Inc. (607378015)
    Establishment
    NameAddressID/FEIBusiness Operations
    Deb USA, Inc.607378015manufacture
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