Forticept Antifungal Cooling
FDA Label NDC 52261-0502

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cosco International, Inc. for the product Forticept Antifungal Cooling (NDC 52261-0502). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient/purpose, uses, warnings, otc - do not use section, otc - when using section, indications & usage section, otc - keep out of reach of children section, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient/purpose

→ Uses

→ Warnings

→ Otc - Do Not Use Section

→ Otc - When Using Section

→ Indications & Usage Section

→ Otc - Keep Out Of Reach Of Children Section

→ Directions

→ Other

→ inactive Ingredients:

→ 60g

→ 120g

Active Ingredient/Purpose

Clotrimazole USP 1%........................Antifungal

Uses

cures most athlete’s foot infections (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis) infections
relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

Warnings

For external use only

Otc - Do Not Use Section

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

Otc - When Using Section

When using this product avoid contact with eyes.

Indications & Usage Section

Stop use and ask a doctor if irritation occurs or there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch).

Otc - Keep Out Of Reach Of Children Section

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wash affected area and dry thoroughly
Spray a thin layer over affected area twice daily (morning and night)
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 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, ask a doctor. This product is not effective on the scalp or nails

Other

Other Information store between 20° - 25°C (68° - 77°F)

Inactive Ingredients:

Aquaxyl, Dicaprylyl Carbonate, Dimethicone, Eucalyptus Oil, Glycerin, Lavender Oil, Montanov L, Oat Milk, Polyhexanide, Sepimax Zen, Simulgel INS100, Sodium Phytate, Sunflower Oil, Tea Tree Oil, Water