PANACHE- triclosan liquid

Panache by

Drug Labeling and Warnings

Panache by is a Otc medication manufactured, distributed, or labeled by Deb USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Triclosan 0.5%

PURPOSE

Antibacterial

INDICATIONS & USAGE

Uses

For washing to decrease bacteria on the skin

WARNINGS

Warnings

For external use only

Avoid contact with the eyes

Keep out of reach of children

Consult with a physician if ingested

DOSAGE & ADMINISTRATION

Directions

Dispense product onto washcloth or directly onto skin

Lather and wash for 15-20 seconds

Rinse thoroughly

INACTIVE INGREDIENT

Water, Sodium Laureth Sulfate, Propylene Glycol, Disodium Laureth Sulfosuccinate, Sodium Chloride, Cocamide DEA, Cocamidopropyl Betaine, Fragrance, Tetrasodium EDTA, Citric Acid, Methylchloroisothiazolinone, Methylisothiazolinone, FDC Red No. 40, FDC Yellow No. 5.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PANACHE   ANTIBACTERIAL BODY WASH
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11084-115
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Triclosan (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X)	Triclosan	.55 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Sodium Laureth Sulfate (UNII: BPV390UAP0)
Propylene Glycol (UNII: 6DC9Q167V3)
Disodium Laureth Sulfosuccinate (UNII: D6DH1DTN7E)
Sodium Chloride (UNII: 451W47IQ8X)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
Edetate Sodium (UNII: MP1J8420LU)
Anhydrous Citric Acid (UNII: XF417D3PSL)
FD&C Red No. 40 (UNII: WZB9127XOA)
FD&C Yellow No. 5 (UNII: I753WB2F1M)
Methylchloroisothiazolinone (UNII: DEL7T5QRPN)
Methylisothiazolinone (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11084-115-34	118 mL in 1 BOTTLE, PLASTIC
2	NDC: 11084-115-27	1000 mL in 1 CARTRIDGE
3	NDC: 11084-115-07	2000 mL in 1 CARTRIDGE
4	NDC: 11084-115-05	3780 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/01/2010

Labeler - Deb USA, Inc. (607378015)

Establishment
Name	Address	ID/FEI	Business Operations
Deb USA, Inc.		607378015	manufacture