24909-104 terrasil tinea treatment max

24909-104 terrasil tinea treatment max
SPL v8
SPL
SPL Set ID d0b14dcb-89a7-42f6-b6ae-8f19c4e6aaaa
Route
topical
Published
Effective Date 2023-11-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
clotrimazole (1 g)
Inactive Ingredients
yellow wax coconut oil cottonseed oil jojoba oil magnesium oxide palm oil peppermint oil sage oil silver stearate tea tree oil witch hazel zinc oxide

Identifiers & Packaging

Marketing Status
otc monograph drug completed Since 2014-05-12 Until 2018-05-21

Purpose

Antifungal

Description

Clotrimazole 1%


Medication Information

Warnings

For external use only. Do not useon 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.

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.

Purpose

Antifungal

Directions

Wash and dry affected skin. Apply a thin layer of ointment 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. May stain fabrics.

Inactive Ingredients

beeswax, coconut oil (organic), cottonseed oil, jojoba oil, magnesium oxide, MCT oil, peppermint oil, sage oil, silver stearate, tea tree oil, witch hazel, zinc oxide

Description

Clotrimazole 1%

Section 50565-1

Keep out of reach of children.

Product Label

Active Ingredient

Clotrimazole 1%


Structured Label Content

Warnings

For external use only. Do not useon 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.

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.

Purpose

Antifungal

Directions

Wash and dry affected skin. Apply a thin layer of ointment 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. May stain fabrics.

Inactive Ingredients (Inactive ingredients)

beeswax, coconut oil (organic), cottonseed oil, jojoba oil, magnesium oxide, MCT oil, peppermint oil, sage oil, silver stearate, tea tree oil, witch hazel, zinc oxide

Section 50565-1 (50565-1)

Keep out of reach of children.

Product Label (Product label)

Active Ingredient (Active ingredient)

Clotrimazole 1%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)