FDA.reportPublic FDA data

DermaZinc Cream

Manufacturer
WynnPharm Inc
Effective date
2025-11-14
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:16:16

Label at a glance#

ProductDermaZinc
Active ingredientPYRITHIONE ZINC
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Pyrithione Zinc 0.25%

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out of Reach of Children.

OTC - PURPOSE SECTION

Seborrheic Dermatitis treatment

DOSAGE & ADMINISTRATION SECTION

Apply to affected area twice daily or as directed by a doctor.

INDICATIONS & USAGE SECTION

For relief of the symptoms of seborrheic dermatitis.

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 aloe barbadensis leaf (aloe vera gel) juice, carbomer, cetyl
alcohol, dimethicone, DMDM hydantoin, glyceryl stearate, isopropyl palmitate, methylparaben,
mineral oil, PEG-75 lanolin, sodium 1auryl sulfate, stearic acid, tocopheryl acetate (vitamin E),
triethanolamine,undecylenic acid, water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DermaZinc CreamDermaZinc Cream

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1306177DermaZinc 0.25 % Topical CreamPSN4
259549zinc pyrithione 0.25 % Topical CreamPSN4
1306177zinc pyrithione 2.5 MG/ML Topical Cream [Dermazinc]SBD4
259549zinc pyrithione 2.5 MG/ML Topical CreamSCD4
1306177Dermazinc 0.25 % Topical CreamSY4
259549zinc pyrithione 0.25 % Topical CreamSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35324-001-04DermaZinc114 g in 1 JARCREAM1144

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
35324-00135324-001-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PEG-75 LANOLIN09179OX7TBIACT
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER 9804Q93RCW27EIACT
CETYL ALCOHOL936JST6JCNIACT
DIMETHICONE 200RGS4T2AS00IACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
STEARIC ACID4ELV7Z65APIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
METHYLPARABENA2I8C7HI9TIACT
DMDM HYDANTOINBYR0546TOWIACT
MINERAL OILT5L8T28FGPIACT
WATER059QF0KO0RIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
TROLAMINE9O3K93S3TKIACT
UNDECYLENIC ACIDK3D86KJ24NIACT

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 Ince72e54ba-03fe-6748-e053-2a95a90a196f2025-11-14WarningsExact identifier
ndc (package): 35324-001-04
ndc (product): 35324-001
ndc11 (package): 35324000104
spl id: 4388139e-9bb0-4c9c-e063-6394a90a4deb
spl set id: e72e54ba-03fe-6748-e053-2a95a90a196f

Reported adverse events (FAERS/openFDA)#

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