FDA.reportPublic FDA data

DermaZinc

Manufacturer
WynnPharm Inc
Effective date
2025-11-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:15:58

Label at a glance#

ProductDermaZinc
Active ingredientPYRITHIONE ZINC
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Pyrithione Zinc 2%

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out of Reach of Children.

OTC - PURPOSE SECTION

Dandruff, Seborrheic Dermatitis treatment

DOSAGE & ADMINISTRATION SECTION


-Use on affected areas in place of regular soap.

-For best results, use at least twice a week, or as directed by your doctor.

-Work up a rich lather using warm water and massage gently into affected areas.

-Rinse well.

INDICATIONS & USAGE SECTION

Controls, reduces and helps stop the symptoms of dandruff and seborrheic dermatitis.

WARNINGS SECTION

Warnings

■ Ask a doctor before use if you have a condition that covers a large area of the body.

When using this product avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with
water.
Stop use and ask a doctor if condition worsens or does not improve after regular use of this
product as directed.

If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.

■ For external use only.

INACTIVE INGREDIENT SECTION

Sodium Palmate, Sodium Cocoate, Water, Glycerin, Avena Sativa (Oat Kernel) Flour, Sodium Chloride, Grape Seed Oil, Olea Europaea (Olive) Fruit Oil, Butyrospermum Parkii (Shea Butter), Theobroma Cacao (Cocoa) Seed Butter, Tetrasodium Glutamate Diacetate, Natural Vitamin E, Pentasodium Pentatate.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dermazinc therapy soapDermazinc therapy soap

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1721127Dermazinc 2 % Medicated ShampooPSN3
244458zinc pyrithione 2 % Medicated ShampooPSN3
1721127zinc pyrithione 20 MG/ML Medicated Shampoo [Dermazinc]SBD3
244458zinc pyrithione 20 MG/ML Medicated ShampooSCD3
1721127Dermazinc 2 % Medicated ShampooSY3
1721127Dermazinc 20 MG/ML Medicated ShampooSY3
244458zinc pyrithione 2 % Medicated ShampooSY3

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130638344000204GTIN-13: 0638344000204
EAN-13: 0638344000204
GTIN-12: 638344000204
UPC-A: 638344000204
GTIN storage (14 digits): 00638344000204		DermaZinc-soap-new-box-design-D2.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35324-004-04DermaZinc120 g in 1 BOXSOAP1203

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
35324-00435324-004-04

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
AVENA SATIVA WHOLE5P8D0Z74RGIACT
GLYCERINPDC6A3C0OXIACT
SODIUM CHLORIDE451W47IQ8XIACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
PENTASODIUM PENTETATE961TOZ5L7TIACT
SHEA BUTTERK49155WL9YIACT
VITAMIN E POLYETHYLENE GLYCOL SUCCINATEO03S90U1F2IACT
OLIVE OIL6UYK2W1W1EIACT
GRAPE SEED OIL930MLC8XGGIACT
SODIUM PALMATES0A6004K3ZIACT
SODIUM PALM KERNELATE6H91L1NXTWIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
WATER059QF0KO0RIACT
COCOA BUTTER512OYT1CRRIACT

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
DermaZincPYRITHIONE ZINCWynnPharm Inc1a3bf938-fd9d-5544-e063-6294a90a9b642025-11-14WarningsExact identifier
ndc (package): 35324-004-04
ndc (product): 35324-004
ndc11 (package): 35324000404
spl id: 43880c01-c2cb-83b8-e063-6294a90ac441
spl set id: 1a3bf938-fd9d-5544-e063-6294a90a9b64

Reported adverse events (FAERS/openFDA)#

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