24909-026 Terrasilmed Antifungal

24909-026 Terrasilmed Antifungal
SPL v2
SPL
SPL Set ID 4059d7b1-43b1-41ad-99c8-11f91280f481
Route
TOPICAL
Published
Effective Date 2024-11-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (1 g)
Inactive Ingredients
Yellow Wax Coconut Oil Silver Stearate Sorbic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-05-08

Description

Clotrimazole 1.0%


Medication Information

Description

Clotrimazole 1.0%

Uses

Proven clinically effective in the treatment of athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). For effective relief of itching, irritation, redness, scaling, cracking, burning, soreness, and discomfort which can accompany these conditions.

Pupose

Antifungal

Section 50565-1

Keep out of reach of children.

Section 60561-8

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

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 2 weeks, discontinue use and consult a physician.

Directions

Wash and dry affected skin. Apply a layer of ointment over affected area twice daily or as directed by a doctor. Supervise children in the use of this product. Store at room temperature. May temporarily (washable) discolor skin, nails, and fabrics in sunlight.

Questions?

401-432-7750 or www.aidance.com

Product Label

Active Ingredient

Clotrimazole 1.0%

Inactive Ingredients

beeswax, MCT (coconut oil), silver stearate, sorbic acid


Structured Label Content

Uses

Proven clinically effective in the treatment of athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). For effective relief of itching, irritation, redness, scaling, cracking, burning, soreness, and discomfort which can accompany these conditions.

Pupose

Antifungal

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 60561-8 (60561-8)

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

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 2 weeks, discontinue use and consult a physician.

Directions

Wash and dry affected skin. Apply a layer of ointment over affected area twice daily or as directed by a doctor. Supervise children in the use of this product. Store at room temperature. May temporarily (washable) discolor skin, nails, and fabrics in sunlight.

Questions?

401-432-7750 or www.aidance.com

Product Label (Product label)

Active Ingredient (Active ingredient)

Clotrimazole 1.0%

Inactive Ingredients (Inactive ingredients)

beeswax, MCT (coconut oil), silver stearate, sorbic acid


Advanced Ingredient Data


Raw Label Data

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