ANTIBACTERIAL MANDARIN- triclosan solution

ANTIBACTERIAL by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

TRICLOSAN 0.6%

PURPOSE

ANTIBACTERIAL

USES

FOR WASHING TO HELP 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 A DOCTOR IF

IRRITATION OR RASH DEVELOPS AND LASTS.

KEEP OUT OF REACH OF CHILDREN

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

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, YELLOW 5 (CI 19140), RED (CI 14700).

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL  MANDARIN
triclosan solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-066
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
WATER (UNII: 059QF0KO0R)
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-066-08	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	08/23/2011

Labeler - TOPCO ASSOCIATES L LLC (006935977)

Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)

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