Seborrheic Dermatitis Therapy Cream

Manufacturer
PSODEX USA INC | BERKO ILAC VE KIMYA SANAYI ANONIM SIRKETI-SULTANBEYLI SUBESI
Effective date
2023-12-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:06:11

Label at a glance#

ProductSeborrheic Dermatitis Therapy
Active ingredientPYRITHIONE ZINC, SALICYLIC ACID
Label structure17 sections

Dosage and administration

Cleanse the skin thoroughly before applying the product Apply to affected areas with a thin layer, one to three times daily or as directed by a doctor

Storage and handling

Store at controlled room temperature 59-86°F

Label contents#

Full prescribing information#

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Allantoin, Ascorbic Acid, Benzoic
Acid, a-Bisabolol, Cetyl Alcohol, Chloroxylenol, Dehydroacetic
Acid, Di-C12-13 Alkyl Malate, Dipropylene Glycol, Distilled
Water, Glyceryl Monostearate, Laureth-9, Mentha Piperita
Extract, Octyldodecanol, Panthenol, Paraffinum Liquidum,
Phenoxyethanol, Undecylenic Acid, Urea, Xanthan Gum, Zinc
Oxide

DESCRIPTION SECTION

Seborrheic Dermatitis is a chronic inflammatory skin condition that can fluctuate over time.

The main goal of treatment is to manage symptoms

PSODEX Seborrheic Dermatitis Therapy Cream offers a soothing formula that helps block the recurrence of Seborrheic Dermatitis symptoms with the help of SALICYLIC ACID and PYRITHIONE ZINC

PREVENTS:
Moisture loss and skin irritation


RELIEVES:
Itching, inflammation, and roughness


CONTROLS:
Flaking, scaling, eruption, and excessive sebum secretion


HELPS BLOCK:
Recurrence of Seborrheic Dermatitis symptoms

INFORMATION FOR OWNERS/CAREGIVERS SECTION

DISTRIBUTED BY: Psodex USA Inc.

9898 Bissonnet St Ste 625 Houston, TX 77036

1-844 4PSODEX www.psodexusa.com

MANUFACTURED FOR

Yesim Derma Laboratories

Active ingredient

DOSAGE & ADMINISTRATION SECTION

Pyrithone Zinc 1%

Salicylic Acid 1,5%

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Pyrithone Zinc 1%

Salicylic Acid 1,5%

Use

INDICATIONS & USAGE SECTION

For the treatment of Seborrheic Dermatitis
Provides relief from the symptoms of Seborrheic Dermatitis, including itching, redness, and scaling of the skin.

Directions

INSTRUCTIONS FOR USE SECTION

Cleanse the skin thoroughly before applying the product
Apply to affected areas with a thin layer, one to three times daily or as directed by a doctor

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

Condition covers a large area of the body

Stop use and ask a doctor if

OTC - STOP USE SECTION

Condition worsens or does not improve after regular use of this product as directed.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Do not use

OTC - DO NOT USE SECTION

On large or deep wounds
On damaged or irritated skin not caused by Seborrheic Dermatitis

When using this product

OTC - WHEN USING SECTION

Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Other information

STORAGE AND HANDLING SECTION

Store at controlled room temperature 59-86°F

Questions or Comments

OTC - QUESTIONS SECTION

1 844 4PSODEX | info@psodexusa.com

Warnings

WARNINGS SECTION

For external use only

Purpose

OTC - PURPOSE SECTION

Seborrheic Dermatitis Treatment

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

packagepackage

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2672357salicylic acid 1.5 % / zinc pyrithione 1 % Topical CreamPSN2
2672357salicylic acid 15 MG/ML / zinc pyrithione 10 MG/ML Topical CreamSCD2
2672357salicylic acid 1.5 % / zinc pyrithione 1 % Topical CreamSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2d2ef081-4f0c-4669-81e8-32b263669a0aProduct name120230801
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
af534dc0-c9e5-19a6-693c-e7ad53714660Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73503-010-00Seborrheic DermatitisTherapy1000 mL in 1 BOTTLE, PUMPCREAM10002
73503-010-01Seborrheic DermatitisTherapy1000 in 1 BOXCREAM10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73503-010SEBORRHEIC DERMATITIS THERAPY (SALICYLIC ACID, PYRITHIONE ZINC) CREAM [PSODEX USA INC]22 package rows20240101_0325265b-5f72-92ae-e063-6294a90a3f05.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73503-01073503-010-00, 73503-010-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 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
0d0ecf5b-0eaf-55c7-e063-6294a90ad69e0325265b-5f72-92ae-e063-6294a90a3f052023-12-21WarningsExact identifier
spl id: 0d0ecf5b-0eaf-55c7-e063-6294a90ad69e
spl set id: 0325265b-5f72-92ae-e063-6294a90a3f05

Reported adverse events (FAERS/openFDA)#

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