84844-001 - DailyMed Details

84844-001

SPL v1

SPL

SPL Set ID 25213ad7-dcd6-ae3d-e063-6394a90a9465

Route

TOPICAL

Published

Effective Date 2024-10-23

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Salicylic Acid (4 g)

Inactive Ingredients

Dimethicone Menthol Borneol Glyceryl 1-stearate Nifedipine Cetyl Alcohol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-10-23

Description

Salicylic Acid 4%

Purpose

Psoriasis and Seborrheic Dermatitis

Medication Information

Purpose

Psoriasis and Seborrheic Dermatitis

Description

Salicylic Acid 4%

Use

relieves and helps prevent recurrence of:

■itching

■irritation

■redness

■flaking

■scaling due to psoriasis and seborrheic dermatitis

Stop Use

condition worsens or does not improve after regular use.

Ask Doctor

if condition worsens or does not improve after regular use.

Directions

apply twice a day or as needed.

Do Not Use

●on children under 2 years of age unless directedby a doctor

●Avoid contact with eyes.

When Using

this product

■avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Active Ingredient

Salicylic Acid 4%

Other Information

store at room temperature.

Inactive Ingredients

Borneol, Cetyl Alcohol, Dimethicone, Glyceryl 1-stearate, Menthol,Nifedipine, etc.

Principal Display Panel

Keep Oot of Reach of Children

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

Structured Label Content

Use

relieves and helps prevent recurrence of:

■itching

■irritation

■redness

■flaking

■scaling due to psoriasis and seborrheic dermatitis

Purpose

Psoriasis and Seborrheic Dermatitis

Stop Use

condition worsens or does not improve after regular use.

Ask Doctor

if condition worsens or does not improve after regular use.

Directions

apply twice a day or as needed.

Do Not Use (Do not use)

●on children under 2 years of age unless directedby a doctor

●Avoid contact with eyes.

When Using

this product

■avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Active Ingredient

Salicylic Acid 4%

Other Information (Other information)

store at room temperature.

Inactive Ingredients (Inactive ingredients)

Borneol, Cetyl Alcohol, Dimethicone, Glyceryl 1-stearate, Menthol,Nifedipine, etc.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

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

Advanced Ingredient Data

[{"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BORNEOL", "unii": "M89NIB437X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERYL 1-STEARATE", "unii": "258491E1RZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "NIFEDIPINE", "unii": "I9ZF7L6G2L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "CETYL ALCOHOL", "unii": "936JST6JCN", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "relieves and helps prevent recurrence of: ■itching ■irritation ■redness ■flaking ■scaling due to psoriasis and seborrheic dermatitis", "Purpose": "Psoriasis and Seborrheic Dermatitis", "Stop Use": "condition worsens or does not improve after regular use.", "Ask Doctor": "if condition worsens or does not improve after regular use.", "Directions": "apply twice a day or as needed.", "Do not use": "●on children under 2 years of age unless directedby a doctor ●Avoid contact with eyes.", "When Using": "this product ■avoid contact with eyes. If contact occurs, rinse thoroughly with water.", "Active Ingredient": "Salicylic Acid 4%", "Other information": "store at room temperature.", "Inactive ingredients": "Borneol, Cetyl Alcohol, Dimethicone, Glyceryl 1-stearate, Menthol,Nifedipine, etc.", "Keep Oot Of Reach Of Children": "If swallowed get medical help or contact a Poison Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:03.112656 · Updated: 2026-03-14T23:04:29.356362