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

Triclosan, 0.5%

Purpose

Antibacterial

Uses

For hand and body washing to reduce bacteria on the skin

Warnings

For external use only

When using this product

Avoid contact with the eyes.  In case of eye contact, flush with water.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Dispense product onto washcloth or directly onto skin

Lather and wash for 15-20 seconds

Rinse and dry thoroughly

Inactive ingredients

Water, Sodium Laureth Sulfate, Propylene Glycol, Disodium Laureth Sulfosuccinate, Sodium Chloride, Cocamidopropyl Betaine, Tetrasodium EDTA, Fragrance, Citric Acid, Magnesium Nitrate, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone, Red 40 (CI 16035), Yellow 5 (CI 19140).

PRINCIPAL DISPLAY PANEL

Panache

Antibacterial Body Wash & Shampoo

deb

Made in USA

Deb USA, Inc.

Charlotte, NC 28217

1-800-248-7190

www.debgroup.com

77027

1 Liter

33.8 Fluid Ounces

Rev. 07-13

INGREDIENTS AND APPEARANCE

PANACHE 
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11084-215
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.50 mg  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)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
EDETATE SODIUM (UNII: MP1J8420LU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
MAGNESIUM NITRATE (UNII: 77CBG3UN78)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11084-215-07	2000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/24/2013	08/01/2020
2	NDC: 11084-215-27	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/24/2013	08/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/24/2013	08/01/2020

Labeler - Deb USA, Inc. (607378015)

Establishment
Name	Address	ID/FEI	Business Operations
Deb USA, Inc.		078805627	manufacture(11084-215)