Tolnaftate, Hydrocortisone

Generic Name: tolnaftate, hydrocortisone

Corticosteroid [EPC]Over-the-Counter (OTC)

Brand Names:

Mycozyl Hc Cream Gel

DESCRIPTION: 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.

Overview

DESCRIPTION: 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.

Uses

INDICATIONS AND 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

DOSAGE AND 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.

Side Effects

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.

Warnings

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.

Pregnancy

Pregnancy: Teratogenic effects - Pregnancy Category C . Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well -controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Storage

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.

Frequently Asked Questions

What is Tolnaftate, Hydrocortisone used for?

INDICATIONS AND 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.

What are the side effects of Tolnaftate, Hydrocortisone?

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.

Can I take Tolnaftate, Hydrocortisone during pregnancy?

Pregnancy: Teratogenic effects - Pregnancy Category C . Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well -controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

What are the important warnings for Tolnaftate, Hydrocortisone?

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.

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Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.