Seborrheic Dermatitis Therapy Cream

SPL v2

SPL

SPL Set ID 0325265b-5f72-92ae-e063-6294a90a3f05

Route

TOPICAL

Published

Effective Date 2024-01-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Pyrithione Zinc (0.2 g) Salicylic Acid (2 g)

Inactive Ingredients

Dipropylene Glycol Undecylenic Acid Zinc Oxide Allantoin Mentha Piperita Leaf Xanthan Gum Cetyl Alcohol Di-c12-13 Alkyl Malate Octyldodecanol Ascorbic Acid Aloe Vera Leaf Panthenol Mineral Oil Phenoxyethanol Urea Levomenol Glyceryl Monostearate Chloroxylenol Benzoic Acid Dehydroacetic Acid Water Polidocanol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-01-01

Description

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

Purpose

Seborrheic Dermatitis Treatment

Medication Information

Purpose

Seborrheic Dermatitis Treatment

Description

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

Use

For the treatment of Seborrheic Dermatitis

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

Section 50744-2

DISTRIBUTED BY: Psodex USA Inc.

9898 Bissonnet St Ste 625 Houston, TX 77036

1-844 4PSODEX www.psodexusa.com

MANUFACTURED FOR

Yesim Derma Laboratories

Section 51945-4

Warnings

For external use only

Directions

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

Do Not Use

On large or deep wounds

On damaged or irritated skin not caused by Seborrheic Dermatitis

Active Ingredient

Pyrithone Zinc 1%

Salicylic Acid 1,5%

Other Information

Store at controlled room temperature 59-86°F

Inactive Ingredients

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

Questions Or Comments

1 844 4PSODEX | [email protected]

When Using This Product

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

Ask A Doctor Before Use If

Condition covers a large area of the body

Stop Use and Ask A Doctor If

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

Keep Out of Reach of Children

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

Structured Label Content

Use

For the treatment of Seborrheic Dermatitis

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

Description (34089-3)

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

Section 50744-2 (50744-2)

DISTRIBUTED BY: Psodex USA Inc.

9898 Bissonnet St Ste 625 Houston, TX 77036

1-844 4PSODEX www.psodexusa.com

MANUFACTURED FOR

Yesim Derma Laboratories

Section 51945-4 (51945-4)

Purpose

Seborrheic Dermatitis Treatment

Warnings

For external use only

Directions

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

Do Not Use (Do not use)

On large or deep wounds

On damaged or irritated skin not caused by Seborrheic Dermatitis

Active Ingredient (Active ingredient)

Pyrithone Zinc 1%

Salicylic Acid 1,5%

Other Information (Other information)

Store at controlled room temperature 59-86°F

Inactive Ingredients

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

Questions Or Comments (Questions or Comments)

1 844 4PSODEX | [email protected]

When Using This Product (When using this product)

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

Ask A Doctor Before Use If (Ask a doctor before use if)

Condition covers a large area of the body

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

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

Keep Out of Reach of Children (Keep out of reach of children)

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

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Use": "For the treatment of Seborrheic Dermatitis Provides relief from the symptoms of Seborrheic Dermatitis, including itching, redness, and scaling of the skin.", "34089-3": "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", "50744-2": "DISTRIBUTED BY: Psodex USA Inc. 9898 Bissonnet St Ste 625 Houston, TX 77036 1-844 4PSODEX www.psodexusa.com MANUFACTURED FOR Yesim Derma Laboratories", "Purpose": "Seborrheic Dermatitis Treatment", "Warnings": "For external use only", "Directions": "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", "Do not use": "On large or deep wounds On damaged or irritated skin not caused by Seborrheic Dermatitis", "Active ingredient": "Pyrithone Zinc 1% Salicylic Acid 1,5%", "Other information": "Store at controlled room temperature 59-86°F", "Inactive Ingredients": "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", "Questions or Comments": "1 844 4PSODEX | info@psodexusa.com", "When using this product": "Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.", "Ask a doctor before use if": "Condition covers a large area of the body", "Stop use and ask a doctor if": "Condition worsens or does not improve after regular use of this product as directed.", "Keep out of reach of children": "If swallowed, get medical help or contact a Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:37.354394 · Updated: 2026-03-14T23:02:16.200124