ANTIBACTERIAL CUCUMBER MELON- triclosan liquid
WEGMANS FOOD MARKETS INC

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 0.115%

PURPOSE

ANTIBACTERIAL

USES

HELPS REDUCE GERMS ON HANDS

WARNINGS

FOR EXTERNAL USE ONLY.

WHEN USING THIS PRODUCT

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

STOP USING THIS PRODUCT AND ASK A DOCTOR IF

IRRITATION AND REDNESS DEVELOPS.

KEEP OUT REACH OF CHILDREN

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

DIRECTIONS

APPLY ONTO WET HANDS, LATHER, WASH AND RINSE.

OTHER INFORMATION

STORE AT ROOM TEMPERATURE.

INACTIVE INGREDIENTS

WATER, SODIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, SODIUM CHLORIDE, DECYL GLUCOSIDE, FRAGRANCE, DMDM HYDANTOIN, PEG-120 METHYL GLUCOSE DIOLEATE, TETRASODIUM EDTA, CITRIC ACID, SODIUM SULFATE, POLYQUATERNIUM-7, PEG-7 GLYCERYL COCOATE, BENZOPHENONE-4, GREEN 5 (CI 61570), YELLOW 5 (CI 19140).

IMAGE OF ANTIBACTERIAL

ANTIBACTERIAL CUCUMBER MELON
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:47124-295
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.115 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
DMDM HYDANTOIN (UNII: BYR0546TOW)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
EDETATE SODIUM (UNII: MP1J8420LU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM SULFATE (UNII: 0YPR65R21J)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)
POLOXAMER 124 (UNII: 1S66E28KXA)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
SULISOBENZONE (UNII: 1W6L629B4K)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:47124-295-08	221 mL in 1 BOTTLE, PUMP

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	06/15/2011

Labeler - WEGMANS FOOD MARKETS INC (059650069)

Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)

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