ANTIBACTERIAL FOAMING- triclosan liquid

ANTIBACTERIAL FOAMING by

Drug Labeling and Warnings

ANTIBACTERIAL FOAMING by is a Otc medication manufactured, distributed, or labeled by TOPCO ASSOCIATES LLC, APOLLO HEALTH AND BEAUTY CARE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

TRICLOSAN 0.6 PERCENT

PURPOSE

ANTIBACTERIAL

USES

HELPS REDUCE 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 EYES THOROUGHLY WITH WATER.

STOP USING THIS PRODUCT AND ASK DOCTOR IF

IRRITATION AND REDNESS DEVELOPS AND LASTS.

DIRECTIONS

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

STORAGE AND HANDLING

STORE AT ROOM TEMPERATURE.

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).

FRONT AND BACK LABELS

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL FOAMING  
triclosan liquid

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

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

Inactive Ingredients
Ingredient Name	Strength
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
WATER (UNII: 059QF0KO0R)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-076-08	222 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	11/02/2011

Labeler - TOPCO ASSOCIATES LLC (006935977)

Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)

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