Label: PACIFIC GARDEN ANTIMICROBIAL, FRAGRANCE FREE, DYE FREE- 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 December 31, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Triclosan 0.45%

  • Purpose

    Antiseptic

  • Use

    Handwash to help reduce bacteria that potentially can cause disease.

  • Warnings

    For external use only

    When using this product

    Avoid contact with eyes. In case of eye contact, flush with water.

    Stop use if irritation or redness develops. If condition persists for more than 72 hours consult a doctor.

    Keep out of reach of children.

    If swallowed, seek immediate medical attention or call a poison control center.

  • Directions

    Wet hands, apply soap, rub hands together vigorously for at least 20 seconds. Rinse and dry hands thoroughly with a disposable paper towel.

  • Inactive Ingredients

    Water(Aqua), Sodium Cumenesulfonate, Decyl Glucoside, Ammonium Lauryl Sulfate, Lactic Acid, Tetrasodium EDTA, Sodium Laureth Sulfate, Aminomethyl Propanol, SD Alcohol 40-B, Propylene Glycol, Isohexadecane, Isopropyl Myristate, Methylchloroisothiazolinone, Methylisothiazolinone.

  • PRINCIPAL DISPLAY PANEL - 1200 mL Bag Label

    pacific
    garden

    Antimicrobial Foam Soap
    Fragrance Free, Dye Free

    4-1200 mL(40.5 FL OZ)

    PRINCIPAL DISPLAY PANEL - 1200 mL Bag Label
  • INGREDIENTS AND APPEARANCE
    PACIFIC GARDEN  ANTIMICROBIAL, FRAGRANCE FREE, DYE FREE
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54622-687
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN4.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    SODIUM CUMENESULFONATE (UNII: 5798KA13PG)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54622-687-371200 mL in 1 BAG; Type 0: Not a Combination Product10/02/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/02/2009
    Labeler - Georgia-Pacific Consumer Products LP (806142217)
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