Skineal Ketoconazole Clobetasol Propionate and Neomycin Sulfate Cream

SKINEAL® Cream

 

DESCRIPTION

5g, 15g tubes of a white to off-white cream with an emulsive base.

 

COMPOSITION

Each gram of cream contains:

Ketoconazole 10 mg Clobetasol Propionate 0.25 mg Neomycin sulfate 5000 IU

 

CLINICAL PHARMACOLOGY

The active ingredient of SKINEAL is ketoconazole, an antifugal agent with a broad-spectrum of activity from the Imidazole group. SKINEAL has extremely potent anti-mycotic actions against dermatophytes, its spectrum of activity normally against following: Candida Albicans, Toulopsis, Cryptococcus, Pityrosporium.

Clobetasol Propionate is a hormone of the cortex that is highly effective as an anti-inflammatory and anti-allergenic agent with little or no side effects.

Neomycin sulfate is an aminoglycoside antibiotic which can treat local infection for external use. The synergies obtained in the composition of the compound results in the cream being highly effective against fungi, bacteria, inflammation and pruritus.

 

INDICATIONS

SKINEAL is indicated for typical treatment of fungal infections of the skin including: Tinea Manus, Tinea Pedis, Tinea Corporis, Tinea Cruris, Tinea Versicolor, Dermatitis, Allergic reactions such as Eczema, Pruritus.

 

CONTRAINDICATIONS

SKINEAL cream is contraindicated in patients with known hypersensitivity to any of its ingredients. SKINEAL is for topical use only and cannot be used for internal or ophthalmic use. Special precautions must be observed during use on pregnant women and children.

 

INTERACTIONS

SKINEAL as a topical cream does not interact with any other product.

 

WARNINGS

A) For external use only. B) Avoid contact eyes. C) Do not exceed prescribed dosage. D) Read carefully before using.

 

PRECAUTIONS

Clinical studies of transcutaneous absorption conducted on animals and humans have proved that the reabsorption rate of ketoconazole cream is negligible; as such SKINEAL can be used in pregnancy under the supervision of a medical doctor .Application to the face or on large areas for longer periods of time than recommended in leaflet should be under a medical doctor’s supervision.

 

ADVERSE REACTIONS

SKINEAL is topical antifungal cream that is well tolerated and has little or no side effects when used properly. On occasion, irritation or burning sensation may occur during treatment. However it is unnecessary to discontinue treatment with SKINEAL. In severe or extreme cases you may contact the doctor.

 

SYMPTOMS OF OVERDOSE AND TREATMENT

SKINEAL is well tolerated, no adverse effect has been observed in the event of overdosage.

 

DOSAGE AND ADMINISTRATION

Apply to the affected area once a day, depending on the severity of the infection, the cream may be applied on the affected area twice daily when necessary. Generally the duration of application depends on the type of infecting organism; Treat as bellows for die following:

Tinea Corporis 2 weeks; Tinea Cruris 2 weeks; Tinea Pedis 4 weeks; Tinea Manus 4 weeks.

Infection normally resistant to antifungal agents 4-6 weeks.

 

STORAGE

Store in a dry place below 25oC and away from the sunlight.

 

CHILDREN’S WARNING

Keep out of reach of children.

 

EXPIRATION DATE

Indicated on the tube and box. Three years from the date of manufacture.

 

VIXA BIOPHARMACEUTICAL CO., LTD

New & High-Tech Industrial Development Zone, China.

 

NAFDAC Reg. No.: 04-6671