Label: FOREST FRESH- triclosan soap

  • 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 April 25, 2014

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  • WARNINGS SECTION

    1) For external use only.

    2) Do not use in the eyes.

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

  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

  • INDICATIONS & USAGE SECTION

    Antiseptic handwash for handwashing to decrease baceria on the skin.

  • OTC - PURPOSE SECTION

    Antiseptic handwash

  • DOSAGE & ADMINISTRATION SECTION

    Moisten surface to be cleaned, apply soap, rub to create lather, and rinse.  Repeat as needed.

  • OTC - ACTIVE INGREDIENT SECTION

    Triclosan

  • INACTIVE INGREDIENT SECTION

    cocamidopropyl betaine

    cocodiethanolamide

    citric acid monohydrate

    FD&C blue No.1

    imidazolidinyl urea

    myristamine oxide

    potassium cocoate

    propylene glycol

    sodium C14-C16 olefin sulfonate

    sodium chloride

    sodium lauryl sulfate

    water

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Forest Fresh 8oz.jpgimage description

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Forest Fresh 16oz.jpgimage description

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Forest Fresh Gal.jpgimage description

  • INGREDIENTS AND APPEARANCE
    FOREST FRESH 
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25113-222
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.004 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    potassium cocoate (UNII: F8U72V8ZXP)  
    MYRISTAMINE OXIDE (UNII: J086PM3RRT)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    IMIDUREA (UNII: M629807ATL)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:25113-222-85241 g in 1 BOTTLE
    2NDC:25113-222-16482.5 g in 1 BOTTLE
    3NDC:25113-222-013860 g in 1 JUG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/29/2014
    Labeler - The Dodge Company, Inc. (001045517)
    Registrant - Bayscience Formulators (162935044)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bayscience Formulators LLC162930544manufacture(25113-222)
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