SPL v1
SPL
SPL Set ID 2fc7544d-29be-1f07-e063-6294a90a5e44
Route
TOPICAL
Published
Effective Date 2025-03-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (1 g)
Inactive Ingredients
Olea Europaea (olive) Fruit Oil Glycerin Fragrance 13576 Sodium Lauroamphoacetate Sucrose Water Aloe Barbadensis Leaf Potassium Cocoyl Glycinate Sorbitol Butyrospermum Parkii (shea) Butter Lauric Acid Sulfur Propanediol Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-25
Description

Coltrimazole 1%

Medication Information

Indications and Usage

Treats and prevents fungal infections including tinea versicolor, ringworm, athlete's foot, and jock itch.

Dosage and Administration

Apply to body and feet during shower or bath. Gently message over the entire body, focusing on affected areas. Rinse thoroughly with water. Use twice daily or as directed by a doctor.

For best results use with RoyceDerm Tinea Treatment Cream.

Description

Coltrimazole 1%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9

Avoid contact with the eyes. If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a physician.

Section 50570-1

For external use only. Do not use on children under two years of age unless directed by a physician.

Section 51727-6

Sorbitol, Sucrose, Stearic Acid, Propanediol, Sodium Lauroamphoacetate, Water, Lauric Acid, Glycerin, Sodium Hydroxide, Butyrospermum Parkii (Shea) Butter, Aloe Barbadensis Leaf Extract, Potassium Cocoyl Glycinate, Olea Europaea (Olive) Fruit Oil, Sulfur, Fragrance.

Section 51945-4

Section 53413-1

Visit www.roycederm.com

Section 55105-1

Anti-fungal

Section 55106-9

Coltrimazole 1%

Section 60561-8

Store at room temperature and out of direct sunlight.

Structured Label Content

Indications and Usage (34067-9)

Treats and prevents fungal infections including tinea versicolor, ringworm, athlete's foot, and jock itch.

Dosage and Administration (34068-7)

Apply to body and feet during shower or bath. Gently message over the entire body, focusing on affected areas. Rinse thoroughly with water. Use twice daily or as directed by a doctor.

For best results use with RoyceDerm Tinea Treatment Cream.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9 (50566-9)

Avoid contact with the eyes. If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a physician.

Section 50570-1 (50570-1)

For external use only. Do not use on children under two years of age unless directed by a physician.

Section 51727-6 (51727-6)

Sorbitol, Sucrose, Stearic Acid, Propanediol, Sodium Lauroamphoacetate, Water, Lauric Acid, Glycerin, Sodium Hydroxide, Butyrospermum Parkii (Shea) Butter, Aloe Barbadensis Leaf Extract, Potassium Cocoyl Glycinate, Olea Europaea (Olive) Fruit Oil, Sulfur, Fragrance.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Visit www.roycederm.com

Section 55105-1 (55105-1)

Anti-fungal

Section 55106-9 (55106-9)

Coltrimazole 1%

Section 60561-8 (60561-8)

Store at room temperature and out of direct sunlight.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:46.860658 · Updated: 2026-03-14T23:08:04.646392