Label: TRICLOSAN - 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 February 16, 2011

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  • ACTIVE INGREDIENT



    Active ingredient                      Purpose
    Triclosan 0.25%...............................Antiseptic Close
  • PURPOSE



    Active ingredient                       Purpose

    Triclosan 0.25%...............................Antiseptic

    Use to decrease bacteria on the skin Close
  • KEEP OUT OF REACH OF CHILDREN


    Keep out of reach of children. If swallowed, get medical help
    or contact a Poison Control Center Immediately.
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  • INDICATIONS & USAGE



    Directions mix in hands with water. Work into a foamy lather.

    Smooth over face and neck. Rinse thoroughly.

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  • WARNINGS


    Warnings For external use only.


    Stop use and ask a doctor if


    - excessive skin irritation develops or condition worsens
    - symptoms last more than 7 days or clear up and occur
    again within a few days.

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


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  • DOSAGE & ADMINISTRATION

    Directions
    - Mix in hands with water. Work into a foamy lather.
    Smooth over face and neck. Rinse thoroughly.

    Other Information do not store in a location where water may enter the bottle


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  • INACTIVE INGREDIENT



    Inactive Ingredients BHT, Butylparaben, C9-15 Alkyl Phosphate,
    Cocamidopropyl Bataine, Ethylparaben, Fragrance, Glycerin,
    Hydroxypropyl Methylcelluose, Lauric Acid, Methylparaben, Myristic Acid,
    Phenoxyethanol, Propylparaben, Triethanolamine, Water, Red 40, Yellow 10

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  • INGREDIENTS AND APPEARANCE
    TRICLOSAN 
    triclosan liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-081
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TRICLOSAN (UNII: 4NM5039Y5X) (UNDECYLENIC ACID - UNII:K3D86KJ24N) TRICLOSAN 29 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) 712 mg  in 1 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-081-20 240 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 06/01/2008
    Labeler - CVS Pharmacy (062312574)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    Name Address ID/FEI Business Operations
    Pharma Pac, LLC 140807475 manufacture
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