FDA.reportPublic FDA data

DermaZinc

Manufacturer
WynnPharm Inc
Effective date
2025-05-25
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:01:33

Label at a glance#

ProductDermaZinc
Active ingredientPYRITHIONE ZINC
Label structure9 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

Anti-dandruff

Seborrheic Dermatitis treatment

DOSAGE & ADMINISTRATION SECTION


Apply to wet hair and massage into hair and scalp; rinse thoroughly

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

INDICATIONS & USAGE SECTION

For relief of the symptoms of seborrheic dermatitis and dandruff.

WARNINGS SECTION

Warnings
■ For external use only.
■ 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.

INACTIVE INGREDIENT SECTION

Inactive ingredients
ammonium laureth sulfate, ammonium lauryl sulfate, citric acid, cocamide DEA, cocamidopropyl
betaine, DMDM hydantoin, isopropyl alcohol, menthol, titanium dioxide, water, FD&C blue #2,
FD&C yellow #5

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DermaZinc ShampooDermaZinc Shampoo

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dermazinc ShampooDermazinc Shampoo

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1721127Dermazinc 2 % Medicated ShampooPSN4
244458zinc pyrithione 2 % Medicated ShampooPSN4
1721127zinc pyrithione 20 MG/ML Medicated Shampoo [Dermazinc]SBD4
244458zinc pyrithione 20 MG/ML Medicated ShampooSCD4
1721127Dermazinc 2 % Medicated ShampooSY4
1721127Dermazinc 20 MG/ML Medicated ShampooSY4
244458zinc pyrithione 2 % Medicated ShampooSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35324-003-08DermaZinc240 mL in 1 BOTTLE, DISPENSINGSHAMPOO2404
35324-003-16DermaZinc473 mL in 1 BOTTLE, DISPENSINGSHAMPOO4734

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35324-003DERMAZINC (PYRITHIONE ZINC) SHAMPOO [WYNNPHARM INC]4Current NDC, Legacy NDC, 2 package rows20250527_e71e87ba-2a62-44f3-e053-2995a90a8b11.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
35324-00335324-003-08, 35324-003-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
COCO DIETHANOLAMIDE92005F972DIACT
MENTHOLL7T10EIP3AIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C BLUE NO. 2L06K8R7DQKIACT
AMMONIUM LAURETH-2 SULFATE698O4Z48G6IACT
AMMONIUM LAURYL SULFATEQ7AO2R1M0BIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
DMDM HYDANTOINBYR0546TOWIACT
ISOPROPYL ALCOHOLND2M416302IACT
WATER059QF0KO0RIACT
FD&C YELLOW NO. 5I753WB2F1MIACT

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 Ince71e87ba-2a62-44f3-e053-2995a90a8b112025-05-25WarningsExact identifier
ndc (package): 35324-003-08
ndc (package): 35324-003-16
ndc (product): 35324-003
ndc11 (package): 35324000316
ndc11 (package): 35324000308
spl id: 35fc83a7-c563-853f-e063-6294a90a4682
spl set id: e71e87ba-2a62-44f3-e053-2995a90a8b11

Reported adverse events (FAERS/openFDA)#

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