Dermoscribe (as Pld) - Seborrheic Dermatitis Cream (69683-202)

SPL v9

SPL

SPL Set ID 2b6bf90b-5d42-4c08-afee-56e13122285e

Route

TOPICAL

Published

Effective Date 2025-10-17

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Sulfur (3 g) Salicylic Acid (1 g) Hydrocortisone

Inactive Ingredients

Aloe Grapefruit Aloe Vera Leaf Oil Cetostearyl Alcohol Carbomer Homopolymer Type C Glycol Stearate Se Sorbitol Glycerin Coconut Oil Polysorbate 20 Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2015-03-23

Description

Sulfur 3%, Salicylic Acid 3%, Hydrocortisone 1%

Purpose

SEBORRHEIC DERMATITIS CREAM

Medication Information

Purpose

SEBORRHEIC DERMATITIS CREAM

Description

Sulfur 3%, Salicylic Acid 3%, Hydrocortisone 1%

Use

For relief of itching, scaling, redness, flaking and irritation associated with seborrheic dermatitis

Section 43683-2

Update drug facts

Section 50565-1

KEEP OUT OF REACH OF CHILDREN. If swallowed, seek medical advice or contact a Poison Control Center immediately

Section 51945-4

Warnings

FOR EXTERNAL USE ONLY.

Ask a doctor before use if condition covers a large area of the body

When using this product avoid contact with eyes. If contact occurs, rinse eye thoroughly with water

Stop use and consult a doctor if condition worsens or does not improve after regular use as directed

Directions

Apply to affected area once or twice daily

Active Ingredients

Sulfur 3%, Salicylic Acid 3%, Hydrocortisone 1%

Inactive Ingredients

Aloe Oil, Carbomer, Ceteryl Alcohol, Coconut Oil, Extract of Aloe Vera, Glycerine, Glycol Sterate, Grapefruit Seed Extract, Polysorbate 20, Purified Water, Sodium Hydroxide, Sorbitol

Structured Label Content

Use (USE)

For relief of itching, scaling, redness, flaking and irritation associated with seborrheic dermatitis

Section 43683-2 (43683-2)

Update drug facts

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN. If swallowed, seek medical advice or contact a Poison Control Center immediately

Section 51945-4 (51945-4)

Purpose (PURPOSE)

SEBORRHEIC DERMATITIS CREAM

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY.

Ask a doctor before use if condition covers a large area of the body

When using this product avoid contact with eyes. If contact occurs, rinse eye thoroughly with water

Stop use and consult a doctor if condition worsens or does not improve after regular use as directed

Directions (DIRECTIONS)

Apply to affected area once or twice daily

Active Ingredients (ACTIVE INGREDIENTS)

Sulfur 3%, Salicylic Acid 3%, Hydrocortisone 1%

Inactive Ingredients (INACTIVE INGREDIENTS)

Aloe Oil, Carbomer, Ceteryl Alcohol, Coconut Oil, Extract of Aloe Vera, Glycerine, Glycol Sterate, Grapefruit Seed Extract, Polysorbate 20, Purified Water, Sodium Hydroxide, Sorbitol

Advanced Ingredient Data

[{"name": "ALOE", "unii": "V5VD430YW9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GRAPEFRUIT", "unii": "O82C39RR8C", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF OIL", "unii": "JQ7YW886UQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETOSTEARYL ALCOHOL", "unii": "2DMT128M1S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER HOMOPOLYMER TYPE C", "unii": "4Q93RCW27E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCOL STEARATE SE", "unii": "6YLY96TQL6", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCONUT OIL", "unii": "Q9L0O73W7L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 20", "unii": "7T1F30V5YH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SULFUR", "unii": "70FD1KFU70", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "HYDROCORTISONE", "unii": "WI4X0X7BPJ", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"USE": "For relief of itching, scaling, redness, flaking and irritation associated with seborrheic dermatitis", "43683-2": "Update drug facts", "50565-1": "KEEP OUT OF REACH OF CHILDREN. If swallowed, seek medical advice or contact a Poison Control Center immediately", "PURPOSE": "SEBORRHEIC DERMATITIS CREAM", "WARNINGS": "FOR EXTERNAL USE ONLY. Ask a doctor before use if condition covers a large area of the body When using this product avoid contact with eyes. If contact occurs, rinse eye thoroughly with water Stop use and consult a doctor if condition worsens or does not improve after regular use as directed", "DIRECTIONS": "Apply to affected area once or twice daily", "ACTIVE INGREDIENTS": "Sulfur 3%, Salicylic Acid 3%, Hydrocortisone 1%", "INACTIVE INGREDIENTS": "Aloe Oil, Carbomer, Ceteryl Alcohol, Coconut Oil, Extract of Aloe Vera, Glycerine, Glycol Sterate, Grapefruit Seed Extract, Polysorbate 20, Purified Water, Sodium Hydroxide, Sorbitol"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:04:19.200426 · Updated: 2026-03-14T23:13:06.603726