Pureskin Seborrheic Dermatitis Eczema Cream

Manufacturer
Stellans Inc.
Effective date
2023-07-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:28:59

Label at a glance#

ProductPureskin Seborrheic Dermatitis Eczema Cream
Active ingredientKETOCONAZOLE
Label structure14 sections

Dosage and administration

Clean the affected area with warm water and dry thoroughly. Apply a thin layer over the affected area two to three times daily and gently massage it 2 minutes, repeat 3 to 5 days after symptoms disappear to control recurrence. Children should use it under the supervision of adults.

Storage and handling

store at 20-25 ℃

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ketoconazole 0.5%

Purpose

OTC - PURPOSE SECTION

seborrheic dermatitis, eczema

Use

INDICATIONS & USAGE SECTION

USES for relief of skin itching, irritation, redness, flaking and scaling associated with seborrheic dermatitis, eczema, folliculitis, or psoriasis, and to help prevent symptom recurrence.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

On open skin wounds
In children less than 6 months of age.

When Using

OTC - WHEN USING SECTION

Avoid contact with eyes. If contact occurs, rinse the eyes immediately with water.
Keep out of the reach of young children.

Stop Use

OTC - STOP USE SECTION

Condition worsens or doesn’t improve after regular use of the product as directed.
You become pregnant, or are planning to become pregnant, while using the product.

Ask Doctor

OTC - ASK DOCTOR SECTION

Condition worsens or doesn’t improve after regular use of the product as directed.
You become pregnant, or are planning to become pregnant, while using the product.

Keep Out Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

Clean the affected area with warm water and dry thoroughly.
Apply a thin layer over the affected area two to three times daily and gently massage it 2 minutes, repeat 3 to 5 days after symptoms disappear to control recurrence.
Children should use it under the supervision of adults.

Other information

STORAGE AND HANDLING SECTION

store at 20-25 ℃

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glycerin, Sodium Hyaluronate, Salicylic Acid,
Rhinacanthus Nasutus Leaf, Heba Violae, Euphorbia Hirta L., Murraya Exotica L., Mentha Canadensis L., Cortexdictamnil, Sophora Flavescens Root, Cnidium Monnieri (L.) Cusson, Smilax Glabra Rhizome, Mosla Cavaleriei H.Lv.,, Phellodendron Amurense Rupr., Fischereuphorbia Root, Gleditsia Sinensis Thorn, Kochia Scoparia, Chlorhexidine Acetate, Stemona Tuberosa Lour

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01010202

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83565-00183565-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
21acf19d-d04e-97ca-e063-6294a90a5e41fff56b94-b74e-039a-e053-6294a90a39182024-09-09WarningsExact identifier
spl set id: fff56b94-b74e-039a-e053-6294a90a3918

Reported adverse events (FAERS/openFDA)#

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