83818-020 Update Manufacturer

83818-020 Update Manufacturer
SPL v3
SPL
SPL Set ID 3a095194-c7ea-7f30-e063-6294a90a7ea1
Route
TOPICAL
Published
Effective Date 2025-07-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (4 g)
Inactive Ingredients
Mometasone Econazole Menthol Dimethicone Borneol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-16

Description

Salicylic acid 4%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Salicylic acid 4%

Use

Clinically proven to treat tinea versicolor, athlete's foot, jock itch, ringworm and seborrheic dermatitis.

Provides effective relief from itching, irritation, redness, scaling, cracking, burning, soreness, and discomfort associated with these conditions.

Stop Use

if irritation occurs or if symptoms do not improve within 2 weeks.

Warnings

For external use only.

Questions

Please contact us:

Email: [email protected]

Website: pharmbanners.com

Ask Doctor

if irritation occurs or if symptoms do not improve within 2 weeks.

Directions

Wash and dry the affected area.

Apply a thin layer of ointment twice daily or as directed by a doctor. Supervise children while using this product.

Do Not Use

on children under 2 years unless directed by a doctor.

When Using

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;Dimethicone;Econazole;Menthol;Mometasone

Principal Display Panel

Keep Out of Reach of Children

If swallowed, seek medical help or contact Poison Control immediately.


Structured Label Content

Use

Clinically proven to treat tinea versicolor, athlete's foot, jock itch, ringworm and seborrheic dermatitis.

Provides effective relief from itching, irritation, redness, scaling, cracking, burning, soreness, and discomfort associated with these conditions.

Purpose

Antifungal

Stop Use

if irritation occurs or if symptoms do not improve within 2 weeks.

Warnings

For external use only.

Questions

Please contact us:

Email: [email protected]

Website: pharmbanners.com

Ask Doctor

if irritation occurs or if symptoms do not improve within 2 weeks.

Directions

Wash and dry the affected area.

Apply a thin layer of ointment twice daily or as directed by a doctor. Supervise children while using this product.

Do Not Use (Do not use)

on children under 2 years unless directed by a doctor.

When Using

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;Dimethicone;Econazole;Menthol;Mometasone

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

If swallowed, seek medical help or contact Poison Control immediately.


Advanced Ingredient Data


Raw Label Data

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