Drug Facts
Active Ingredient/Purpose
Clotrimazole - 1% (Antifungal)
Forticept Antifungal Foot Cream
FDA Label NDC 72127-0801
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Lidan, Inc. for the product Forticept Antifungal Foot Cream (NDC 72127-0801). 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 drug facts, uses, indications & usage, warnings:, otc - keep out of reach of children, otc - do not use, otc - ask doctor, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
• Cures most athlete's foot, jock itch and ringworm
• Relieves itching, burning, cracking, scaling and discomfort which accompany these conditions
• Helps keep feet dry and free of fungal infection
Indications & Usage
For the treatment of fungal infections caused by: Athlete's foot (tinea pedis), Jock itch (tinea cruris), and Ringworm (tinea corporis)
Warnings:
For external use only!
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away
Otc - Do Not Use
Do not use on children under 2 years of age unless directed by a doctor.
Otc - Ask Doctor
Stop use and ask a doctor if:
• irritation occurs
• there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch).
Otc - When Using
When using this product avoid contact with eyes.
Directions:
Adults and children 2 years of age and older:
• wash affected area and dry thoroughly
• apply a thin layer over affected area once or twice daily
• 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
Inactive Ingredients:
ALUMINUM STARCH OCTENYLSUCCINATE, CETEARETH-20, CETOSTEARYL ALCOHOL, DIPROPYLENE GLYCOL, ETHYLHEXYLGLYCERIN, GLYCERYL MONOSTEARATE, HYPROMELLOSE, ISOPROPYL MYRISTATE, ISOPROPYL PALMITATE, TEA TREE OIL, PEPPERMINT OIL, PHENOXYETHANOL, POLIHEXANIDE, WATER
Other Information:
• To open: unscrew cap and remove the seal.
• Store between 68° - 77°F (20° - 25°C)
For Questions:
Please call: +1 212 709-8133
Lidan, Inc.
30 Wall Street, 8th Floor
New York, NY 10005
www.forticept.com
Package Label.Principal Display Panel
Forticept Antifungal Foot Cream Tube Label (Forticept.antifungal.foot.cream.4oz)
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