PANACHE- triclosan liquid
Deb USA, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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).

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

product label.jpg

PANACHE
triclosan liquid

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.50 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/24/2013	08/01/2020

Labeler - Deb USA, Inc. (607378015)

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

Revised: 12/2017

Document Id: 64dc5381-fa00-4918-931a-2af6ea4a727a

Set id: c5bf7e96-ce2a-409d-9f0b-c531115b2cb6

Version: 2

Effective Time: 20171207

Deb USA, Inc.