Label: 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 September 12, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient:

    Triclosan (0.35%)

  • Purpose:

    Antiseptic Hand Cleanser

  • Uses

    • Handwash to help reduce bacteria that potentially can cause disease.
    • Recommended for repeated use.
  • Warning

    • For external use only
    • Do not use near eyes

    • Keep out of reach of children.

    Discontinue use if irritation and redness develop. If condition persists more than 72 hours, consult a doctor.

    In case of eye contact, flush with water for 15 minutes. If irritation persists, get medical attention. In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

  • Directions

    • Wet hands and forearms
    • Apply appropriate amount to hands and forearms
    • Scrub hands and forearms thoroughly for 60 seconds
    • Use scrub and/or nail brush to aid in cleaning.
    • Rinse well
    • Wipe dry with towel, repeat as necessary.
  • Other Information

    • Assists with OSHA bloodborne pathogen standard compliance
  • Inactive Ingredients

    Water, Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Propylene Glycol, Lauramide DEA, Cocamide DEA, Cocamidopropyl betaine, Sodium Cumene Sulfonate, Citric Acid, Fragrance, DMDM Hydantoin, Sodium Chloride, FD&C Green #3.

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel

    Bio CLEAN

    Foaming Antiseptic Hand Cleaner

    A powerful antiseptic cleanser for handwashing

    • Enhanced with moisturizers
    • Reduces bacteria on skin that can potentially cause disease
    • Assists with OSHA bloodborne pathogen standard compliance

    KEEP OUT OF REACH OF CHILDREN

    CAUTION

    See Drug Facts for panel for additional information.

    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    TRICLOSAN 
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53119-575
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN3.15 g  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    sodium laureth sulfate (UNII: BPV390UAP0)  
    sodium lauryl sulfate (UNII: 368GB5141J)  
    propylene glycol (UNII: 6DC9Q167V3)  
    lauric diethanolamide (UNII: I29I2VHG38)  
    cocamidopropyl betaine (UNII: 5OCF3O11KX)  
    coco diethanolamide (UNII: 92005F972D)  
    citric acid monohydrate (UNII: 2968PHW8QP)  
    dmdm hydantoin (UNII: BYR0546TOW)  
    sodium chloride (UNII: 451W47IQ8X)  
    FD&C Green NO. 3 (UNII: 3P3ONR6O1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53119-575-201100 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/11/2010
    Labeler - Columbia Jobbing (032769788)
    Registrant - Canberra Corporation (068080621)
    Establishment
    NameAddressID/FEIBusiness Operations
    Canberra Corporation068080621MANUFACTURE(53119-575)
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