24909-106 Terrasil Antifungal Treatment Max

24909-106 Terrasil Antifungal Treatment Max
SPL v12
SPL
SPL Set ID db356cc8-f473-4eb2-b8d8-72606fca9dc0
Route
TOPICAL
Published
Effective Date 2023-10-25
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 Stearic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2012-09-07 Until 2024-05-15

Description

Clotrimazole 1%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Clotrimazole 1%

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.

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 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.

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.

Product Label

Active Ingredient

Clotrimazole 1%

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, sage oil, silver stearate, tea tree oil, vegetable stearic acid (naturally sourced)*, witch hazel, zinc oxide

*may contain this ingredient


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.

Purpose

Antifungal

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 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.

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.

Product Label (Product label)

Active Ingredient

Clotrimazole 1%

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, sage oil, silver stearate, tea tree oil, vegetable stearic acid (naturally sourced)*, witch hazel, zinc oxide

*may contain this ingredient


Advanced Ingredient Data


Raw Label Data

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