Pacific Garden Antimicrobial, Fragrance Free, Dye Free (Triclosan) Soap [Georgia-Pacific Consumer Products Lp] -

PACIFIC GARDEN ANTIMICROBIAL, FRAGRANCE FREE, DYE FREE (TRICLOSAN) SOAP [GEORGIA-PACIFIC CONSUMER PRODUCTS LP]
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NDC	54622-687-37
Set ID	d605d9c2-7dc2-4960-87e8-1bce2c6a6025
Category	HUMAN OTC DRUG LABEL
Packager	Georgia-Pacific Consumer Products LP
Generic Name
Product Class
Product Number
Application Number	PART333E

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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)

INGREDIENTS AND APPEARANCE

PACIFIC GARDEN ANTIMICROBIAL, FRAGRANCE FREE, DYE FREE
triclosan soap

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	4.5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54622-687-37	1200 mL in 1 BAG; Type 0: Not a Combination Product	10/02/2009

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	10/02/2009

Labeler - Georgia-Pacific Consumer Products LP (806142217)

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Medic