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 0.46%

Purpose

Antibacterial

Uses

Helps reduce bacteria on the skin.

Warnings

For external use only.

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 develop.

Keep out of reach of children

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

Directions

Pump onto dry hands, work into a lather and rinse thoroughly.

Other information

Store at room temperature.

Inactive Ingredients

WATER, SODIUM XYLENESULFONATE, DIPROPYLENE GLYCOL, GLYCERIN, SODIUM PCA, AMMONIUM LAURYL SULFATE, COCAMIDOPROPYL BETAINE, POLYQUATERNIUM-10, FRAGRANCE, DISODIUM PHOSPHATE, CETYL ALCOHOL, ALOE BARBADENSIS LEAF JUICE, CITRIC ACID, METHYLPARABEN, PROPYLPARABEN, RED 4 (CI 14700), 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: 36800-177
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.46 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)
CETYL ALCOHOL (UNII: 936JST6JCN)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-177-08	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	11/07/2011

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