ANTIBACTERIAL FOAMING - triclosan liquid
SUPERVALU 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 0.6%

Purpose

Antibacterial

Uses

For washing to decrease bacteria on the skin.

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 doctor if

Irritation or redness develops and lasts.

Keep out of reach of children

In case of accidental ingestion, get medical help and contact a Poison Control Center immediately.

Directions

Apply onto wet hands, work into a lather vigorously. Rinse thoroughly.

Questions or Comments

1-877-932-7948

Inactive Ingredients

WATER, SODIUMXYLENE SULFONATE, DIPROPYLENE GLYCOL, AMMONIUM LAURYL SULFATE, COCAMIDOPROPYL BETAINE, FRAGRANCE, DISODIUM PHOSPHATE, CITRIC ACID, RED 4 (CI 14700), YELLOW 5 (CI 19140).

ANTIBACTERIAL FOAMING
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41163-168
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.6 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41163-168-08	222 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	10/24/2011

Labeler - SUPERVALU INC (006961411)

Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)

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