24909-046 Terrasil Fungal Treatment

24909-046 Terrasil Fungal Treatment
SPL v1
SPL
SPL Set ID 278290f9-be14-81a8-e063-6294a90ad8cc
Route
TOPICAL
Published
Effective Date 2025-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (1 g)
Inactive Ingredients
Sodium Citrate Sodium Laurate Sodium Laureth Sulfate Sodium Myristate Sodium Oleate Sodium Olivate Sodium Stearate Titanium Dioxide Citric Acid Monohydrate Propylene Glycol Peppermint Oil Tea Tree Oil Etidronate Tetrasodium Silver Stearate Magnesium Oxide Sodium Chloride Sodium Lauryl Sulfate Shea Butter Water Zinc Oxide Tetrasodium Iminodisuccinate Yellow Wax Medium-chain Triglycerides Sorbitol Jojoba Oil Glycerin Lavender Oil Palm Oil Cottonseed Oil Coconut Oil Stearic Acid Sage Oil Witch Hazel

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-01

Description

Ointment: Clotrimazole 1% Soap Bar: Clotrimazole 1%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Ointment: Clotrimazole 1% Soap Bar: Clotrimazole 1%

Uses

Treats Athlete’s foot (tinea pedis), Jock itch (tinea cruris),

Ringworm (tinea corporis). Relieves Itching, burning, cracking.

Section 42229-5

Retain Carton for Product Information

Questions? 401-432-7750 or www.aidance.com

Section 50565-1

Keep out of reach of children.

Section 51945-4

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 doctor. Avoid contact with the eyes. If irritation occurs or if there is no improvement within 4 weeks, or 2 weeks for jock itch, discontinue use and consult a doctor.

Directions

Wash affected area well with soap, rinse area after one to two minutes. Dry thoroughly. Apply a layer of ointment over affected area. Use twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. For athlete’s foot: Pay special attention to spaces between the toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily. For athlete’s foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor. This product is not effective on the scalp or nails. For best results use both Terrasil Antifungal Ointment and Soap Bar. Store at room temperature. Ointment may temporarily (washable) discolor skin, nails, and fabrics in sunlight.

Active Ingredients

Ointment: Clotrimazole 1%

Soap Bar: Clotrimazole 1%

Inactive Ingredients

Ointment: 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

Soap Bar: beeswax, citric acid, glycerin, jojoba oil, lavender oil, magnesium oxide, MCT oil, peppermint oil, propylene glycol, silver stearate, sodium chloride, sodium citrate, sodium laurate, sodium laureth sulfate, sodium lauryl sulfate, sodium myristate, sodium oleate, sodium olivate, sodium shea butterate, sodium stearate, sorbitol, tea tree oil, tetrasodium etidronate, tetrasodium iminodisuccinate, titanium dioxide, water, zinc oxide

*may contain this ingredient


Structured Label Content

Uses

Treats Athlete’s foot (tinea pedis), Jock itch (tinea cruris),

Ringworm (tinea corporis). Relieves Itching, burning, cracking.

Section 42229-5 (42229-5)

Retain Carton for Product Information

Questions? 401-432-7750 or www.aidance.com

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51945-4 (51945-4)

Section 60561-8 (60561-8)

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

Purpose

Antifungal

Warnings

For external use only.

Do not use on children under two years of age unless directed by a doctor. Avoid contact with the eyes. If irritation occurs or if there is no improvement within 4 weeks, or 2 weeks for jock itch, discontinue use and consult a doctor.

Directions

Wash affected area well with soap, rinse area after one to two minutes. Dry thoroughly. Apply a layer of ointment over affected area. Use twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. For athlete’s foot: Pay special attention to spaces between the toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily. For athlete’s foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor. This product is not effective on the scalp or nails. For best results use both Terrasil Antifungal Ointment and Soap Bar. Store at room temperature. Ointment may temporarily (washable) discolor skin, nails, and fabrics in sunlight.

Active Ingredients (Active ingredients)

Ointment: Clotrimazole 1%

Soap Bar: Clotrimazole 1%

Inactive Ingredients (Inactive ingredients)

Ointment: 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

Soap Bar: beeswax, citric acid, glycerin, jojoba oil, lavender oil, magnesium oxide, MCT oil, peppermint oil, propylene glycol, silver stearate, sodium chloride, sodium citrate, sodium laurate, sodium laureth sulfate, sodium lauryl sulfate, sodium myristate, sodium oleate, sodium olivate, sodium shea butterate, sodium stearate, sorbitol, tea tree oil, tetrasodium etidronate, tetrasodium iminodisuccinate, titanium dioxide, water, zinc oxide

*may contain this ingredient


Advanced Ingredient Data


Raw Label Data

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