NATURALTECH PURIFYING ANTI-DANDRUFF- pyrithione zinc gel 
Davines S.p.A.

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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NATURALTECH PURIFYING ANTI-DANDRUFF Gel

Active Ingredient

Zinc Pyrithione 0,48%

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

Other information

Inactive Ingredients

Water, Polysorbate 20, Pentasodium Pentetate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Propylene Glycol, Glycerin, Bisabolol, Piroctone Olamine, Taraxacum Officinale (Dandelion) Root Extract, Tocopherol, Tetrasodium EDTA, Sodium Hydroxide, Linalool, Fragrance.

PRINCIPAL DISPLAY PANEL - 150 mL Bottle Carton Label

NATURALTECH™

PURIFYING ANTI-DANDRUFF GEL

TREATMENT FOR SCALP WITH

OILY OR DRY DANDRUFF

WITH DANDELION PHYTOCEUTICALS

150 mL 5.07 Fl. Oz.

davines

gel

NATURALTECH PURIFYING ANTI-DANDRUFF 
pyrithione zinc gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64724-1017
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.48 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
LEVOMENOL (UNII: 24WE03BX2T)  
PIROCTONE OLAMINE (UNII: A4V5C6R9FB)  
TARAXACUM OFFICINALE (UNII: 39981FM375)  
TOCOPHEROL (UNII: R0ZB2556P8)  
EDETATE SODIUM (UNII: MP1J8420LU)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64724-1017-11 in 1 CARTON02/29/2012
1150 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM03202/29/2012
Labeler - Davines S.p.A. (430193664)
Registrant - Davines S.p.A. (430193664)
Establishment
NameAddressID/FEIBusiness Operations
Biokosmes SRL436948830manufacture(64724-1017)

Revised: 11/2022
Document Id: ee8b1e5d-07f2-f1c4-e053-2a95a90afd06
Set id: 1f7e0265-0543-4ef9-addf-4d514d0eedfe
Version: 4
Effective Time: 20221128
 
Davines S.p.A.