Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: Mycozyl HC™ Cream Gel is supplied in a 1 oz / 28 gm tube with CRC cap ( NDC 59088-279-03). Store at 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature]. Protect from freezing and excessive heat. Keep container tightly closed. Use under the direction of a licensed healthcare 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. Manufactured by: PureTek Corporation Panorama City, CA 91402 For questions or information call toll-free: 877-921-7873; Mycozyl HC TM Cream Gel Label
- HOW SUPPLIED: Mycozyl HC™ Cream Gel is supplied in a 1 oz / 28 gm tube with CRC cap ( NDC 59088-279-03). Store at 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature]. Protect from freezing and excessive heat. Keep container tightly closed. Use under the direction of a licensed healthcare 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. Manufactured by: PureTek Corporation Panorama City, CA 91402 For questions or information call toll-free: 877-921-7873
- Mycozyl HC TM Cream Gel Label
Overview
Mycozyl HC™ Cream Gel contains 10 mg of tolnaftate and 6.67 mg of hydrocortisone in a vehicle consisting of: Allantoin, Aminomethyl Propanol, Aqua (Purified Water), Argania Spinosa (Argan) Kernel Oil, Carbomer, Ethylhexylglycerin, Eucalyptus Globulus (Eucalyptus) Leaf Oil, Glycerin, Lavandula Angustifolia (Lavender Flower) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Phenoxyethanol, Polysorbate 20, Propylene Glycol. Chemically, hydrocortisone is [Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11ß)-], with the molecular formula C21H30O5 and molecular weight 362.47 and is represented by the following structural formula: Chemically, tolnaftate molecular formula is C19H17NOS and molecular weight 314.5 and is represented by the following structure formula: Hydrocortisone is an anti-inflammatory and antipruritic agent, while tolnaftate is an antifungal agent. Structure Structure
Indications & Usage
: Mycozyl HC™ Cream Gel is indicated for treatment of fungal infection of the skin and for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage & Administration
: Clean the affected area and dry thoroughly. Apply a thin layer of the 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 licensed healthcare practitioner.
Warnings & Precautions
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.
Adverse Reactions
The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.
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