FDA.reportPublic FDA data

NATURALTECH PURIFYING ANTI-DANDRUFF Gel

Manufacturer
Davines S.p.A. | Biokosmes SRL
Effective date
2024-12-11
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:42:14

Label at a glance#

ProductNATURALTECH PURIFYING ANTI-DANDRUFF
Active ingredientPYRITHIONE ZINC
Label structure11 sections

Indications and uses

For relief of the symptoms of dandruff

Dosage and administration

Spread carefully over the whole scalp, or only on areas affected by dandruff, massaging in gently. Leave to process for 10 minutes. Rinse thoroughly. For best results use at least twice a week or as directed by a doctor.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Pyrithione 0,48%

Purpose

OTC - PURPOSE SECTION

Antidandruff

Uses

INDICATIONS & USAGE SECTION

For relief of the symptoms of dandruff

Warnings

WARNINGS SECTION

For external use only

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition worsens or does not improve after regular use

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Spread carefully over the whole scalp, or only on areas affected by dandruff, massaging in gently.
  • Leave to process for 10 minutes.
  • Rinse thoroughly.
  • For best results use at least twice a week or as directed by a doctor.

Other information

SPL UNCLASSIFIED SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NATURALTECH™

PURIFYING ANTI-DANDRUFF GEL

TREATMENT FOR SCALP WITH

OILY OR DRY DANDRUFF

WITH DANDELION PHYTOCEUTICALS

150 mL 5.07 Fl. Oz.

davines

gelgel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1245937zinc pyrithione 0.48 % Topical GelPSN5
1245937zinc pyrithione 4.8 MG/ML Medicated ShampooSCD5
1245937zinc pyrithione 0.48 % Topical GelSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64724-1017-1NATURALTECH PURIFYING ANTI-DANDRUFF1 in 1 CARTONGEL15
64724-1017-1NATURALTECH PURIFYING ANTI-DANDRUFF150 mL in 1 BOTTLEGEL1505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64724-1017NATURALTECH PURIFYING ANTI-DANDRUFF (PYRITHIONE ZINC) GEL [DAVINES S.P.A.]5Current NDC, Legacy NDC, 2 package rows20241213_1f7e0265-0543-4ef9-addf-4d514d0eedfe.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PYRITHIONE ZINCACTIVE INGREDIENTR953O2RHZ51
PYRITHIONE ZINCACTIVE MOIETYR953O2RHZ51
CARBOMER INTERPOLYMER TYPE A (55000 MPA.S)INACTIVE INGREDIENT59TL3WG5CO1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LU1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
LEVOMENOLINACTIVE INGREDIENT24WE03BX2T1
LINALOOL, (+/-)-INACTIVE INGREDIENTD81QY6I88E1
PENTASODIUM PENTETATEINACTIVE INGREDIENT961TOZ5L7T1
PIROCTONE OLAMINEINACTIVE INGREDIENTA4V5C6R9FB1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YH1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I1
TARAXACUM OFFICINALEINACTIVE INGREDIENT39981FM3751
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P81
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64724-101764724-1017-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
POLYSORBATE 207T1F30V5YHIACT
PENTASODIUM PENTETATE961TOZ5L7TIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
LEVOMENOL24WE03BX2TIACT
PIROCTONE OLAMINEA4V5C6R9FBIACT
TARAXACUM OFFICINALE39981FM375IACT
TOCOPHEROLR0ZB2556P8IACT
EDETATE SODIUMMP1J8420LUIACT
SODIUM HYDROXIDE55X04QC32IIACT
LINALOOL, (+/-)-D81QY6I88EIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 22 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / TOPICAL4522 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CREAM / TOPICALNAExact identifier — unii+route
2 equally ranked IID candidates
PENTASODIUM PENTETATEPENTASODIUM PENTETATE961TOZ5L7TSOAP / TOPICALNAExact identifier — unii+route
2 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CREAM / TOPICALNAExact identifier — unii+route
2 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSOAP / TOPICAL0.12 %w/wExact identifier — unii+route
10 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / TOPICAL70 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LULOTION / TOPICAL0.17 %w/wExact identifier — unii+route
10 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / TOPICAL4522 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LULOTION / TOPICAL0.17 %w/wExact identifier — unii+route
10 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSHAMPOO / TOPICAL1.33 %w/wExact identifier — unii+route
10 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSPONGE / TOPICAL0.14 %w/wExact identifier — unii+route
10 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route
10 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSHAMPOO / TOPICAL1.33 %w/wExact identifier — unii+route
10 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHGEL / TOPICAL5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route
10 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHGEL / TOPICAL5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / TOPICAL70 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSOAP / TOPICAL0.12 %w/wExact identifier — unii+route
10 equally ranked IID candidates
PENTASODIUM PENTETATEPENTASODIUM PENTETATE961TOZ5L7TSOAP / TOPICALNAExact identifier — unii+route
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSPONGE / TOPICAL0.14 %w/wExact identifier — unii+route
10 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NATURALTECH PURIFYING ANTI-DANDRUFFPYRITHIONE ZINCDavines S.p.A.1f7e0265-0543-4ef9-addf-4d514d0eedfe2024-12-11WarningsExact identifier
ndc (package): 64724-1017-1
ndc (product): 64724-1017
ndc11 (package): 64724101701
spl id: 28ff9fbd-1d80-1984-e063-6294a90abb69
spl set id: 1f7e0265-0543-4ef9-addf-4d514d0eedfe

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.