FDA.reportPublic FDA data

Dandrene

Manufacturer
DIVINE SKIN LABORATORIES S.A. de C.V. | A.I.G. Technologies, Inc.
Effective date
2020-11-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:34:23

Label at a glance#

ProductDandrene
Active ingredientPYRITHIONE ZINC
Label structure9 sections

Indications and uses

Relieves and helps prevent recurrence of scalp itch, irritation, redness, flaking and scaling associated with dandruff.

Dosage and administration

Apply shampoo to wet hair and scalp with a gentle massage, leave in for 2-3 minutes, rinse. For best results use at least 2 times per week or as directed by a doctor. For maximum benefit use 4-5 times a week along with Dandrene Anti-Dandruff Conditioner.

Label contents#

Full prescribing information#

​Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Pyrithione zinc 2% w/w

​Purpose

OTC - PURPOSE SECTION

Anti-dandruff

​Uses

INDICATIONS & USAGE SECTION

Relieves and helps prevent recurrence of scalp itch, irritation, redness, flaking and scaling associated with dandruff.

​Warnings

WARNINGS SECTION

​For external use only.

When using this product: Avoid​​ contact with eyes.  If contact occurs, rinse eyes thoroughly with water. ​

OTC - STOP USE SECTION

​Stop use and ask a doctor if: ​Condition worsens or does not improve after regular use of this product as directed.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

​Directions

DOSAGE & ADMINISTRATION SECTION

Apply shampoo to wet hair and scalp with a gentle massage, leave in for 2-3 minutes, rinse.

For best results use at least 2 times per week or as directed by a doctor.

For maximum benefit use 4-5 times a week along with Dandrene Anti-Dandruff Conditioner.

​Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Sodium Lauryl Sulfoacetate, Disodium Laureth Sulfosuccinate, Sodium Lauroyl Sarcosinate, Triethanolamine, Glycolic Acid, Cocamide MEA, Glyceryl Stearate, PEG-150 Distearate, Magnesium Aluminum Silicate, Sodium Citrate, Hexamidine Diisethionate, Hydrolyzed Lupine Protein, Caprylyl Glycol, Phenoxyethanol, Butylene Glycol, Pomegranage Peel (Punica Granutum) Extract, Rosemary (Rosmarinus Officinalis) Leaf Extract, Shikimic Acid, Tioxolone, Emu Oil, Fragrance, Blue 1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

boxboxlabellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2059178Dandrene 2 % Medicated ShampooPSN2
244458zinc pyrithione 2 % Medicated ShampooPSN2
2059178zinc pyrithione 20 MG/ML Medicated Shampoo [Dandrene]SBD2
244458zinc pyrithione 20 MG/ML Medicated ShampooSCD2
2059178Dandrene 2 % Medicated ShampooSY2
2059178Dandrene 20 MG/ML Medicated ShampooSY2
244458zinc pyrithione 2 % Medicated ShampooSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72249-100-012022-01-28C16284748780-1d6a99b39-8020-a426-e053-dadaa90af4c2Dandrene Anti-Dandruff Shampoo

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72249-100-01Dandrene1 in 1 BOXSHAMPOO12
72249-100-01Dandrene205 g in 1 BOTTLESHAMPOO2052

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72249-100DANDRENE (PYRITHIONE ZINC) SHAMPOO [DIVINE SKIN LABORATORIES S.A. DE C.V.]2Legacy NDC, 2 package rows20201201_3be1c394-2a9b-447b-90c8-422a1e483f0c.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72249-10072249-100-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
PYRITHIONE ZINCR953O2RHZ5ACTIB
WATER059QF0KO0RIACT
SODIUM LAURYL SULFOACETATED0Y70F2B9JIACT
DISODIUM LAURETH SULFOSUCCINATED6DH1DTN7EIACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
TROLAMINE9O3K93S3TKIACT
GLYCOLIC ACID0WT12SX38SIACT
COCO MONOETHANOLAMIDEC80684146DIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-150 DISTEARATE6F36Q0I0ACIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
SODIUM CITRATE1Q73Q2JULRIACT
HEXAMIDINE DIISETHIONATE023XA5Z50LIACT
LUPINUS ALBUS SEED24GB753W3BIACT
CAPRYLYL GLYCOL00YIU5438UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
POMEGRANATE FRUIT RINDRS999V57DUIACT
ROSMARINUS OFFICINALIS WHOLEEA3289138MIACT
SHIKIMIC ACID29MS2WI2NUIACT
TIOXOLONES0FAJ1R9CDIACT
EMU OIL344821WD61IACT

Source Document#

Source XML

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
d560e0d3-bbe5-4a35-8fc8-873f03485bd63be1c394-2a9b-447b-90c8-422a1e483f0c2020-11-30WarningsExact identifier
spl id: d560e0d3-bbe5-4a35-8fc8-873f03485bd6
spl set id: 3be1c394-2a9b-447b-90c8-422a1e483f0c

Reported adverse events (FAERS/openFDA)#

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