Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 9a5eb581-62a2-41fe-a174-e852fc47e235
Route
TOPICAL
Published
Effective Date 2023-10-27
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 Glycerin Lauric Acid Lavender Oil Olive Oil Pentasodium Pentetate Shea Butter Sodium Chloride Sodium Citrate Sodium Laurate Sodium Laureth Sulfate Sodium Lauryl Sulfate Sodium Myristate Sodium Oleate Sodium Olivate Sodium Stearate Sorbitol Etidronate Tetrasodium Titanium Dioxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-02

Description

Clotrimazole 1%                                Antifungal

Purpose

Clotrimazole 1%                                Antifungal


Medication Information

Purpose

Clotrimazole 1%                                Antifungal

Description

Clotrimazole 1%                                Antifungal

Uses

Ointment: 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.

Cleansing Bar: For relief of most fungal skin infection symptoms.

Section 50565-1

Section 55105-1

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

Ointment: 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.

Cleaning Bar: Wash affected area daily. For best results use with

terrasil® Antifungal ointment products.

Product Label

Other Information

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

Inactive Ingredients

Ointment: 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

Cleansing Bar: beeswax (organic), coconut oil, glycerin, jojoba oil, lauric acid, lavender oil, magnesium oxide, olive oil, pentasodium pentetate, peppermint oil, shea butter (butyrospermum), silver stearate, sodium chloride, sodium citrate, sodium laurate, sodium laureth sulfate, sodium lauryl sulfate, sodium myristate, sodium oleate, sodium olivate, sodium stearate, sorbitol, tea tree oil, tetrasodium etidronate, titanium dioxide, water, zinc oxide

Active Ingredient                                  purpose

Clotrimazole 1%                                Antifungal


Structured Label Content

Uses

Ointment: 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.

Cleansing Bar: For relief of most fungal skin infection symptoms.

Section 50565-1 (50565-1)

Section 55105-1 (55105-1)

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

Ointment: 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.

Cleaning Bar: Wash affected area daily. For best results use with

terrasil® Antifungal ointment products.

Product Label (Product label)

Other Information (Other information)

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

Inactive Ingredients

Ointment: 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

Cleansing Bar: beeswax (organic), coconut oil, glycerin, jojoba oil, lauric acid, lavender oil, magnesium oxide, olive oil, pentasodium pentetate, peppermint oil, shea butter (butyrospermum), silver stearate, sodium chloride, sodium citrate, sodium laurate, sodium laureth sulfate, sodium lauryl sulfate, sodium myristate, sodium oleate, sodium olivate, sodium stearate, sorbitol, tea tree oil, tetrasodium etidronate, titanium dioxide, water, zinc oxide

Active Ingredient                                  purpose (Active Ingredient                                  Purpose)

Clotrimazole 1%                                Antifungal


Advanced Ingredient Data


Raw Label Data

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