Dermgentle Seborrheic Face Cream

Manufacturer
Dermgentle LLC | PRIME ENTERPRISES, LLC
Effective date
2025-12-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:22:34

Label at a glance#

ProductDermgentle Seborrheic Face Cream
Active ingredientPYRITHIONE ZINC
Label structure7 sections

Indications and uses

For the relief of the symptoms of seborrheic dermatitis such as skin flaking, redness, irritation and itching.

Dosage and administration

Adults and children 12 years of age and older: • cleanse the skin gently and pat dry • apply a thin layer of Seborrheic Face Cream to affected areas of the face and other seborrheic areas (such as eyebrows, sides of nose, and hairline) • apply to affected areas one to four times daily or as directed by a doctor Children under 12 years of age: ask a doctor.

Label contents#

Full prescribing information#

Indications and usage

INDICATIONS & USAGE SECTION

For the relief of the symptoms of seborrheic dermatitis such as skin flaking, redness, irritation and itching.

Dosage and administration

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older:

• cleanse the skin gently and pat dry

• apply a thin layer of Seborrheic Face Cream to affected areas of the face and other seborrheic areas (such as eyebrows, sides of nose, and hairline)

• apply to affected areas one to four times daily or as directed by a doctor

Children under 12 years of age: ask a doctor.

Warnings

WARNINGS SECTION

For external use only.

When using this product

• avoid contact with eyes. If product gets into eyes, rinse eyes thoroughly with water.

Ask a doctor before use if

• condition covers a large area of the body.

Do not use

• on skin that is broken or inflamed

• if you are allergic to ingredients in this product.

Stop use and ask a doctor if

• rash appears

• 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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua (water, eau), caprylic/capric triglyceride, glycerin, squalane, xylitol, cetyl alcohol, cetearyl alcohol, sodium stearoyl lactylate, phenoxyethanol.

Purpose

OTC - PURPOSE SECTION

Seborrheic dermatitis treatment.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Principal display panel and Drug Facts

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal display panel and Drug Facts labeling for Dermgentle Seborrheic Face Cream (Pyrithione zinc 0.1%).

Front Panel Principal DisplayFront Panel Principal Display

Drug FactsDrug Facts

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
247812zinc pyrithione 0.1 % Topical CreamPSN2
247812zinc pyrithione 1 MG/ML Topical CreamSCD2
247812zinc pyrithione 0.1 % Topical CreamSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87261-100-01Dermgentle Seborrheic Face Cream57 g in 1 JARCREAM572

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87261-10087261-100-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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
Dermgentle Seborrheic Face CreamPYRITHIONE ZINCDermgentle LLC45232668-6953-80a0-e063-6294a90a6e4b2025-12-12WarningsExact identifier
ndc (package): 87261-100-01
ndc (product): 87261-100
ndc11 (package): 87261010001
spl id: 458124b2-bce7-4ea7-e063-6394a90a616e
spl set id: 45232668-6953-80a0-e063-6294a90a6e4b

Reported adverse events (FAERS/openFDA)#

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