Antibacterial

ANTIBACTERIAL - triclosan soap
Personal Care Products LLC

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.

----------

Active Ingredient

Triclosan 0.2%

Purpose antibacterial

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

Uses

for hand washing to decrease bacteria on the skin.

Warnings

For external use only.

When using this product avoid contact with eyes. In case of eye contact, flush with water.

Stop use and ask a doctor if irritation and redness develops.

Directions

Pump into hands

Lather vigorously for at least 15 seconds

Rinse and dry thoroughly

Inactive ingredients

Water (aqua), sodium laureth sulfate, sodium chloride, coamide DEA, DMDM hydantoin, fragrance, citric acid, tetrasodium EDTA, yellow #5, red #40

Kills 99% of germs

Antibacterial soap

Moisterizing hand soap

15 fl oz (444 ml)

ANTIBACTERIAL
triclosan soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:29500-903
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (TRICLOSAN)	TRICLOSAN	.888 mL in 444 mL

Inactive Ingredients
Ingredient Name	Strength
WATER
SODIUM LAURETH SULFATE
SODIUM CHLORIDE
COCO DIETHANOLAMIDE
DMDM HYDANTOIN
CITRIC ACID MONOHYDRATE
EDETATE SODIUM
FD&C YELLOW NO. 5

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:29500-903-85	444 mL in 1 BOTTLE, PUMP	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/01/2011

Labeler - Personal Care Products LLC (966155082)

Registrant - Personal Care Products LLC (966155082)

Establishment
Name	Address	ID/FEI	Operations
Ningbo Pulisi Daily Chemical Products		529047265	manufacture

Establishment
Name	Address	ID/FEI	Operations
Ningbo United Group Co Ltd		528196956	manufacture

Revised: 06/2011 Personal Care Products LLC