ANTIBACTERIAL REFILL- triclosan liquid
KMART CORPORATION

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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DRUG FACTS

ACTIVE INGREDIENT

TRICLOSAN 0.15%

PURPOSE

ANTIBACTERIAL

USES

FOR HAND WASHING TO DECREASE BACTERIA ON THE SKIN.

WARNINGS

FOR EXTERNAL USE ONLY.

WHEN USING THIS PRODUCT

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

STOP USING THIS PRODUCT AND ASK DOCTOR IF

IRRITATION AND REDNESS DEVELOPS.

KEEP OUT OF REACH OF CHILDREN

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

DIRECTIONS

APPLY ONTO WET HANDS, WORK INTO A LATHER, RINSE THOROUGHLY.

QUESTIONS OR COMMENTS

1-800-842-7886

INACTIVE INGREDIENTS

WATER, SODIUM LAURETH SULFATE, COCAMIDROPROPYL BETAINE, SODIUM CHLORIDE, COCAMIDOPROPYL HYDROXYSULTAINE, GLYCERIN, FRAGRANCE, POLYQUATERNIUM-7, PPG-2 HYDROXYETHYL COCO/ISOSTEARAMIDE, DMDM HYDANTOIN, TETRASODIUM EDTA, CITRIC ACID, YELLOW 5 (CI 19140), RED 4 (CI 14700).

IMAGE OF LABEL

ANTIBACTERIAL REFILL
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49738-294
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.15 L in 100 L

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
GLYCERIN (UNII: PDC6A3C0OX)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)
DMDM HYDANTOIN (UNII: BYR0546TOW)
EDETATE SODIUM (UNII: MP1J8420LU)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49738-294-08	0.221 L in 1 BOTTLE, PUMP

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	06/27/2011

Labeler - KMART CORPORATION (008965873)

Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)

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