MedPath

DermaZinc

DermaZinc Shampoo

Approved
Approval ID

e71e87ba-2a62-44f3-e053-2995a90a8b11

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 25, 2025

Manufacturers
FDA

WynnPharm Inc

DUNS: 620885173

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

pyrithione zinc

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code35324-003
Application NumberM032
Product Classification
M
Marketing Category
C200263
G
Generic Name
pyrithione zinc
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 25, 2025
FDA Product Classification

INGREDIENTS (13)

ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
COCO DIETHANOLAMIDEInactive
Code: 92005F972D
Classification: IACT
MENTHOLInactive
Code: L7T10EIP3A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
AMMONIUM LAURETH-2 SULFATEInactive
Code: 698O4Z48G6
Classification: IACT
AMMONIUM LAURYL SULFATEInactive
Code: Q7AO2R1M0B
Classification: IACT
PYRITHIONE ZINCActive
Quantity: 2 g in 100 mL
Code: R953O2RHZ5
Classification: ACTIB
COCAMIDOPROPYL BETAINEInactive
Code: 5OCF3O11KX
Classification: IACT
DMDM HYDANTOINInactive
Code: BYR0546TOW
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/25/2025

Dermazinc Shampoo

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/29/2022

For relief of the symptoms of seborrheic dermatitis and dandruff.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/29/2022

Pyrithione Zinc 2%

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/29/2022

Keep Out of Reach of Children.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/29/2022

Anti-dandruff

Seborrheic Dermatitis treatment

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/29/2022

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.

WARNINGS SECTION

LOINC: 34071-1Updated: 8/29/2022

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

LOINC: 51727-6Updated: 8/29/2022

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

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DermaZinc - FDA Drug Approval Details