24909-207 terrasil athlete's foot treament max

24909-207 terrasil athlete's foot treament max
SPL v6
SPL
SPL Set ID fce478a0-05f5-4606-82ce-c8dd095df211
Route
topical
Published
Effective Date 2023-11-08
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 silver stearate tea tree oil zinc oxide

Identifiers & Packaging

Marketing Status
otc monograph drug completed Since 2022-01-05 Until 2026-05-30

Purpose

Antifungal

Description

Clotrimazole 1%


Medication Information

Warnings

For external use only. Do not use onchildren 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. Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Uses

Proven clinically effective in the treatment of athlete’s foot (tinea pedis), athlete's foot (dermatophytosis). 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 layer of ointment over affected area daily for 4 weeks or as directed by a doctor. Pay special attention to spaces between the toes; wear wellfitting, ventilated shoes, and change shoes and socks at least once daily. Supervise children in the use of this product. This product is not effective on the scalp or nails.

Other Information

Store at room temperature. May temporarily (washable) discolor skin and fabrics in sunlight

Inactive Ingredients

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

Description

Clotrimazole 1%

Questions?

401-432-7750 or www.aidance.com

Section 50565-1

Product Label

Active Ingredient

Clotrimazole 1%


Structured Label Content

Warnings

For external use only. Do not use onchildren 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. Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Uses

Proven clinically effective in the treatment of athlete’s foot (tinea pedis), athlete's foot (dermatophytosis). 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 layer of ointment over affected area daily for 4 weeks or as directed by a doctor. Pay special attention to spaces between the toes; wear wellfitting, ventilated shoes, and change shoes and socks at least once daily. Supervise children in the use of this product. This product is not effective on the scalp or nails.

Other Information (Other information)

Store at room temperature. May temporarily (washable) discolor skin and fabrics in sunlight

Inactive Ingredients

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

Questions?

401-432-7750 or www.aidance.com

Section 50565-1 (50565-1)

Product Label (Product label)

Active Ingredient

Clotrimazole 1%


Advanced Ingredient Data


Raw Label Data

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