83887-005

83887-005
SPL v1
SPL
SPL Set ID 2e89c938-e69f-1323-e063-6294a90aebdb
Route
TOPICAL
Published
Effective Date 2025-02-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sophora Flavescens Root (2 g) Ketoconazole (1 g)
Inactive Ingredients
Stemona Tuberosa Whole Smilax Glabra Tuber Dryobalanops Aromatica Whole Gleditsia Triacanthos Whole Bassia Scoparia Fruit Mentha Canadensis Whole

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-20
Description

Sophora Flvescens 2% Stemona tuberosa 1%

Purpose

Seborrheic dermatitis,PsoriasisAnti-fungal, Anti itchy

Medication Information

Purpose

Seborrheic dermatitis,PsoriasisAnti-fungal, Anti itchy

Description

Sophora Flvescens 2% Stemona tuberosa 1%

Use

Temporarily relieves and helps prevent the recurrence of scalp itching, flaking, scaling, redness, and irritation associated with psoriasis and seborrheic dermatitis.

Stop Use

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

Warnings

For external use only.

Allergy Alert: Consult a doctor before use if you are allergic to any ingredients in this product.

Questions

[email protected]

Ask Doctor

Condition worsens after regular use as directed.

Directions

1 Gently massage scalp shampoo into your wet hair.

2 Leave shampoo for 5-7 minutes in the hair.

3 Gently massage into a lather and rinses cleanly away.

4 For best results, Repeat step 3.

Do Not Use

On damaged or inflamed scalp.

If you are pregnant or breastfeeding.

In children under 12 years old.

When Using

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

Active Ingredient

Sophora Flvescens 2%

Stemona tuberosa 1%

Other Information

Store at room temperature, away from directsunlight.

Inactive Ingredients

Latintite

gleditsia Inenesislinn

typhon Img i gateueng

Rhizoma Smi Lacis Glabrae

Dryobalanops spp

Stemona tuberosa

Menthacanadaensis L

Principal Display Panel

Keep Oot of Reach of Children

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

Structured Label Content

Use

Temporarily relieves and helps prevent the recurrence of scalp itching, flaking, scaling, redness, and irritation associated with psoriasis and seborrheic dermatitis.

Purpose

Seborrheic dermatitis,PsoriasisAnti-fungal, Anti itchy

Stop Use

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

Warnings

For external use only.

Allergy Alert: Consult a doctor before use if you are allergic to any ingredients in this product.

Questions

[email protected]

Ask Doctor

Condition worsens after regular use as directed.

Directions

1 Gently massage scalp shampoo into your wet hair.

2 Leave shampoo for 5-7 minutes in the hair.

3 Gently massage into a lather and rinses cleanly away.

4 For best results, Repeat step 3.

Do Not Use (Do not use)

On damaged or inflamed scalp.

If you are pregnant or breastfeeding.

In children under 12 years old.

When Using

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

Active Ingredient

Sophora Flvescens 2%

Stemona tuberosa 1%

Other Information (Other information)

Store at room temperature, away from directsunlight.

Inactive Ingredients (Inactive ingredients)

Latintite

gleditsia Inenesislinn

typhon Img i gateueng

Rhizoma Smi Lacis Glabrae

Dryobalanops spp

Stemona tuberosa

Menthacanadaensis L

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 Control Center immediately.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:35.377890 · Updated: 2026-03-14T23:07:39.601528