Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 63ea5248-7722-4c66-b11c-fdebfb9a8ca0
Route
TOPICAL
Published
Effective Date 2012-01-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (1.0 g)
Inactive Ingredients
Bentonite Jojoba Oil Magnesium Oxide Peppermint Oil Silver Oxide Tea Tree Oil White Wax Zinc Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-01-26
Description

Clotrimazole 1.0%

Purpose

Antifungal

Medication Information

Purpose

Antifungal

Description

Clotrimazole 1.0%

Uses
  • Cures most fungal skin infections, including ringworm and tinea. 
  • For effective relief of itching, scaling, cracking, burning, discoloration, soreness, irritation, discomfort, redness and chafing associated with fungal skin infections.
Section 51945-4

Place holder text

Warnings

For external use only. Do not use on children under two years of age unless directed by a physician. Avoid contact with the eyes. If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a physician.

Directions

Wash and dry affected skin. Apply a thin layer of Terrasil over the affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. Store at room temperature.

Active Ingredient

Clotrimazole 1.0%

Inactive Ingredients

(Organic) Beeswax, Bentonite, Magnesium Oxide, Peppermint Oil, Silver Oxide, Simmondsia Chinensis (Jojoba) Seed Oil, Tea Tree Oil, Zinc Oxide

Keep Out of Reach of Children.

If swallowed, call poison control or seek medical help.

Structured Label Content

Uses
  • Cures most fungal skin infections, including ringworm and tinea. 
  • For effective relief of itching, scaling, cracking, burning, discoloration, soreness, irritation, discomfort, redness and chafing associated with fungal skin infections.
Section 51945-4 (51945-4)

Place holder text

Purpose

Antifungal

Warnings

For external use only. Do not use on children under two years of age unless directed by a physician. Avoid contact with the eyes. If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a physician.

Directions

Wash and dry affected skin. Apply a thin layer of Terrasil over the affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. Store at room temperature.

Active Ingredient

Clotrimazole 1.0%

Inactive Ingredients

(Organic) Beeswax, Bentonite, Magnesium Oxide, Peppermint Oil, Silver Oxide, Simmondsia Chinensis (Jojoba) Seed Oil, Tea Tree Oil, Zinc Oxide

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, call poison control or seek medical help.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:24.488287 · Updated: 2026-03-14T22:52:58.895821