NATURALTECH PURIFYING ANTI-DANDRUFF- selenium sulfide shampoo

NATURALTECH PURIFYING ANTI-DANDRUFF by

Drug Labeling and Warnings

NATURALTECH PURIFYING ANTI-DANDRUFF by is a Otc medication manufactured, distributed, or labeled by Davines S.p.A., Biokosmes SRL . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Selenium Sulfide, micronized 0,6 %

Purpose

Antidandruff

Uses

for relief of the symptoms of dandruff

Warnings

For external use only

Stop use and ask a doctor if condition worsens or does not improve after regular use.

When using this product keep out of eyes. Rinse with water to remove.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• wet hair
• apply shampoo and work into a lather
• rinse thoroughly
• for best results, use at least twice a week or as directed by a doctor

Other information

• you may report a serious adverse event from using this product to Report Reaction, LLC PO Box 22, Plainsboro, NJ

Inactive ingredients

Water, Cocamidopropyl Betaine, Propylene Glycol, Sodium Lauryl Glucose Carboxylate, Glycerin, Lauryl Glucoside, Sodium Lauroyl Methyl Isethionate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Glyceryl Oleate, Taraxacum Officinale (Dandelion) Root Extract, Coco-Glucoside, Polysorbate 20, Sodium Benzoate, Citric Acid, Sodium Chloride, Trisodium Ethylenediamine Disuccinate, Potassium Sorbate, 2-Bromo-2-Nitropropane-1,3-Diol, Fragrance.

PRINCIPAL DISPLAY PANEL - 1000 mL Bottle Label

NATURALTECH™

PURIFYING ANTI-DANDRUFF SHAMPOO

SHAMPOO FOR SCALP WITH OILY OR DRY DANDRUFF

WITH DANDELION PHYTOCEUTICALS

1000 mL 33.81 Fl. Oz.

davines

INGREDIENTS AND APPEARANCE

NATURALTECH PURIFYING ANTI-DANDRUFF 
selenium sulfide shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64724-1016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q)	SELENIUM SULFIDE	0.6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
GLYCERYL OLEATE (UNII: 4PC054V79P)
TARAXACUM OFFICINALE (UNII: 39981FM375)
COCO GLUCOSIDE (UNII: ICS790225B)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
BRONOPOL (UNII: 6PU1E16C9W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64724-1016-1	12 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/29/2012
2	NDC: 64724-1016-2	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/29/2012
3	NDC: 64724-1016-3	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/29/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	02/29/2012

Labeler - Davines S.p.A. (430193664)

Establishment
Name	Address	ID/FEI	Business Operations
Biokosmes SRL		436948830	manufacture(64724-1016)