FDA.reportPublic FDA data

AntiDandruffShampoo

Manufacturer
Peer Pharm Ltd.
Effective date
2016-06-21
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 22:46:20

Label at a glance#

ProductAntiDandruffShampoo
Active ingredientPYRITHIONE ZINC
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Arganicare PDPArganicare PDP

OTC - ACTIVE INGREDIENT SECTION

Zinc Pyrithione 1.0%

OTC - PURPOSE SECTION

Controls Dandruff

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

INDICATIONS & USAGE SECTION

Controls itching and flaking associated with dandruff

INACTIVE INGREDIENT SECTION

WARNINGS SECTION

For external use only. Avoid contact with eyes. If contact occurs, rinse eyes throughly with water. If condition worsens or does not improve after regular use of this product as directed, consult a doctor.

DOSAGE & ADMINISTRATION SECTION

Wet hair, apply shampoo and work into a lather. Rinse thoroughly with warm water. For best results, use at least twice a week or as direct by a doctor.

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
209884zinc pyrithione 1 % Medicated ShampooPSN5
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD5
209884zinc pyrithione 1 % Medicated ConditionerSY5
209884zinc pyrithione 1 % Medicated ShampooSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69435-1608-12021-01-29C16284748780-1ba0f9c33-4ab7-a910-e053-dadaa90a0b85Arganicare Anti-Dandruff Shampoo

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69435-1608-1AntiDandruffShampoo400 mL in 1 BOTTLESHAMPOO4005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69435-1608ANTIDANDRUFFSHAMPOO (PYRITHIONE ZINC SHAMPOO) SHAMPOO [PEER PHARM LTD.]5Legacy NDC, 1 package rows20160621_2eb93d7c-333d-4b93-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69435-160869435-1608-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
COCO MONOETHANOLAMIDEC80684146DIACT
GLYCOL DISTEARATE13W7MDN21WIACT
PANTHENOLWV9CM0O67ZIACT
WATER059QF0KO0RIACT
AMMONIUM LAURETH-12 SULFATEE1ZP93931SIACT
GLYCERINPDC6A3C0OXIACT
JOJOBA OIL724GKU717MIACT
HAMAMELIS VIRGINIANA TOP WATERNT00Y05A2VIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
POLYQUATERNIUM-39 (22.5/51/26.5 ACRYLIC ACID/ACRYLAMIDE/DADMAC; 1600000 MW)X2NH1K9F8KIACT
C12-15 ALKYL LACTATEGC844VRD7EIACT
PEG-12 DIMETHICONE (300 CST)ZEL54N6W95IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
DMDM HYDANTOINBYR0546TOWIACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)B16G315W7AIACT
ACRYLAMIDOPROPYLTRIMONIUM CHLORIDE/ACRYLAMIDE COPOLYMER (400 MPA.S)2RX4MI2LCXIACT
SHEANUT OILO88E196QRFIACT
LACTIC ACID33X04XA5ATIACT
EDETATE SODIUMMP1J8420LUIACT
SODIUM BENZOATEOJ245FE5EUIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
COCAMIDOPROPYL HYDROXYSULTAINE62V75NI93WIACT
ARGAN OIL4V59G5UW9XIACT
CARBOMER 1342809Y72KV36IACT

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
35c88007-95d8-7283-e054-00144ff8d46c2eb93d7c-333d-4b93-e054-00144ff88e882016-06-21WarningsExact identifier
spl id: 35c88007-95d8-7283-e054-00144ff8d46c
spl set id: 2eb93d7c-333d-4b93-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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