tolnaftate 10 MG/ML Topical Solution [Fungi-Nail Reformulated Mar 2019]

INDICATIONS AND USAGE: Mycozyl AL™ is effective in the treatment of most skin infections such as athlete's foot (tinea pedis) and ringworm (tinea corporis). Mycozyl AL™ has been designed to reach skin areas around and under the nails while it relives burning, cracking, scaling and discomfort which accompany these conditions. Mycozyl AL™ is an antifungal that works by preventing and eliminating the growth of fungus on fingers, toes and around the nails. It eliminates and helps stop the spread of fungal infections on cuticles around nail edges and under the nail tips where reachable with applicator brush. Mycozyl AL™ cures and prevents fungal infections from coming back with daily use.

DOSAGE AND ADMINISTRATION: • Clean the affected area with soap and warm water and dry thoroughly • Apply a thin layer of product over affected area twice daily (morning and night) paying special attention to the edges of the nail, cuticles and skin around the nails or as directed by a doctor • The brush applicator allows for easy application on skin around the nail and cuticle areas. • 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. • Supervise children in the use of this product. Use under the direction of a licensed medical practitioner. Call your doctor about side effects. To report side effects, call PureTek Corporation at 1-877-921-7873 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 1

WARNINGS: For External Use Only. Not For Ophthalmic Use

CONTRAINDICATIONS: This product is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

CLINICAL PHARMACOLOGY: Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. Tolnaftate has antifungal properties.