fortinia ultra antifungal solution

fortinia ultra antifungal solution
SPL v2
SPL
SPL Set ID 43065a59-fb81-b1c2-e063-6294a90a36e0
Route
topical
Published
Effective Date 2025-11-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
clotrimazole (1 g)
Inactive Ingredients
cymbopogon flexuosus leaf thymus vulgaris (thyme) flower/leaf oil eugenia caryophyllus (clove) leaf oil polysorbate 80 urea caprylic/capric triglyceride cinnamomum zeylanicum leaf oil polysorbate 20 cinnamomum camphora (camphor) bark oil aqua alcohol cilantro

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-11-10

Purpose

Antifungal

Description

Clotrimazole 1%


Medication Information

Warnings

• Do not use on children under 2 years of age unless directed by a doctor.

• For external use only

• Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

• If irritation occurs or there is no improvement within 4 weeks, discontinue use and consult a doctor.

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

Uses

Uses

• Cures athlete’s foot (dermatophytosis) and ringworm (tinea corporis)

• Relieves • itching • burning • cracking • scaling • discomfort

Purpose

Antifungal

Directions

Wash affected area and dry thoroughly. Apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by your doctor. Supervise children in the use of this product. For athlete’s foot: pay special attention to spaces between 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. If condition persists longer, consult your doctor. This product is not effective on the scalp or nails.

Other Information

Store at room temperature (68°-77°F). Using the brush provided or a disposable cotton swab, spread the liquid on the desired area. After each application, wash and dry brush thoroughly (or discard cotton swab).

Inactive Ingredients

Alcohol Denat., Caprylic/Capric Triglyceride, Cinnamomum Camphora (Camphor) Bark Oil, Cinnamomum Zeylanicum (Cinnamon) Leaf Oil, Coriandrum Sativum (Cilantro) Leaf/Stem Oil, Cymbopogon Flexuosus (Lemongrass) Leaf Oil, Eugenia Caryophyllus (Clove) Leaf Oil, Polysorbate 20, Polysorbate 80, Thymus Vulgaris (Thyme) Leaf Oil, Urea, Water (Aqua)

Description

Clotrimazole 1%

Principal Display Panel

Precautions

Keep out of reach of children.

Active Ingredients

Clotrimazole 1%


Structured Label Content

Warnings (WARNINGS)

• Do not use on children under 2 years of age unless directed by a doctor.

• For external use only

• Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

• If irritation occurs or there is no improvement within 4 weeks, discontinue use and consult a doctor.

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

Uses (USES)

Uses

• Cures athlete’s foot (dermatophytosis) and ringworm (tinea corporis)

• Relieves • itching • burning • cracking • scaling • discomfort

Purpose (PURPOSE)

Antifungal

Directions (DIRECTIONS)

Wash affected area and dry thoroughly. Apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by your doctor. Supervise children in the use of this product. For athlete’s foot: pay special attention to spaces between 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. If condition persists longer, consult your doctor. This product is not effective on the scalp or nails.

Other Information (OTHER INFORMATION)

Store at room temperature (68°-77°F). Using the brush provided or a disposable cotton swab, spread the liquid on the desired area. After each application, wash and dry brush thoroughly (or discard cotton swab).

Inactive Ingredients (INACTIVE INGREDIENTS)

Alcohol Denat., Caprylic/Capric Triglyceride, Cinnamomum Camphora (Camphor) Bark Oil, Cinnamomum Zeylanicum (Cinnamon) Leaf Oil, Coriandrum Sativum (Cilantro) Leaf/Stem Oil, Cymbopogon Flexuosus (Lemongrass) Leaf Oil, Eugenia Caryophyllus (Clove) Leaf Oil, Polysorbate 20, Polysorbate 80, Thymus Vulgaris (Thyme) Leaf Oil, Urea, Water (Aqua)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Precautions (PRECAUTIONS)

Keep out of reach of children.

Active Ingredients (ACTIVE INGREDIENTS)

Clotrimazole 1%


Advanced Ingredient Data


Raw Label Data

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