ANTIBACTERIAL FOAMING - triclosan liquid
TOPCO ASSOCIATES 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.

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ACTIVE INGREDIENT

TRICLOSAN 0.6 PERCENT

PURPOSE

ANTIBACTERIAL

USES

FOR HAND WASHING TO DECREASE BACTERIA ON THE SKIN.

WARNINGS

FOR EXTERNAL USE ONLY.

KEEP OUT OF REACH OF CHILDREN

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

WHEN USING THIS PRODUCT

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER.

STOP USING THIS PRODUCT AND ASK DOCTOR IF

IRRITATION OR RASH DEVELOPS AND LASTS.

DIRECTIONS

PUMP ONTO DRY HANDS, VIGOROUSLY WORK INTO A LATHER AND RINSE THOROUGHLY.

INACTIVE INGREDIENTS

WATER, SODIUM XYLENESULFONATE, SODIUM LAURETH SULFATE, DIPROPYLENE GLYCOL,COCAMIDOPROPYL BETAINE, POLYSORBATE 20, FRAGRANCE, DISODIUM PHOSPHATE, CITRIC ACID, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, RED 33 (CI 17200), YELLOW 5 (CI 19140).

IMAGE OF LABEL

ANTIBACTERIAL FOAMING
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-076
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (TRICLOSAN)	TRICLOSAN	0.6 mL in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM XYLENESULFONATE
DIPROPYLENE GLYCOL
SODIUM LAURETH SULFATE
COCAMIDOPROPYL BETAINE
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE
CITRIC ACID MONOHYDRATE
D&C RED NO. 33
FD&C YELLOW NO. 5
WATER
POLYSORBATE 20
METHYLISOTHIAZOLINONE
METHYLCHLOROISOTHIAZOLINONE

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:36800-076-08	222 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	part333E	08/23/2011

Labeler - TOPCO ASSOCIATES LLC (006935977)

Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)

Establishment
Name	Address	ID/FEI	Operations
APOLLO HEALTH AND BEAUTY CARE		201901209	manufacture

Revised: 08/2011 TOPCO ASSOCIATES LLC