Product Description.:
Each gram of Dermazene? Cream 1% contains 10 mg of hydrocortisone and 10 mg of iodoquinol in a cream base of purified water, propylene glycol, cerasynt SE, amerchol L101, isopropyl palmitate, cetyl alcohol, arlacel 60, myrj 52, tween 60, sorbic acid, methyl paraben and propyl paraben.
Indications and Usage:
Based on a review of a related drug by the National Research Council and subsequent FDA classification for that drug, the indications are as follows: ?Possibly? Effective: Contact or atopic dermatitis impetiginized eczema nummular eczema infantile eczema endogenous chronic infectious dermatitis stasis dermatitis pyoderma nuchal eczema and chronic eczematoid otitis externa acne urticata localized or disseminated neurodermatitis lichen simplex chronicus anogenital pruritus (vulvae, scroti, ani) folliculitis bacterial dermatoses mycotic dermatoses such as tinea (capitis, cruris, corporis, pedis) moniliasis, intertrigo. Final classification of the less-than-effective indications requires further investigation.
Contraindications:
Dermazene Cream is contraindicated in those patients with a history of hypersensitivity to hydrocortisone, iodoquinol or any other components of the preparation.
Warnings and Precautions:
For external use only. Keep away from eyes. If irritation develops, the use of Dermazene Cream should be discontinued and appropriate therapy instituted. Staining of the skin and fabrics may occur. If extensive areas are treated or if the occlusive technique is used, the possibility exists of increased systemic absorption of the corticosteroid, and suitable precautions should be taken. Children may absorb proportionally larger amounts of the corticosteroids and thus be more susceptible to systemic toxicity. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings. Iodoquinol may be absorbed through the skin and interfere with thyroid function tests. If such tests are contemplated, wait at least one month after discontinuance of therapy to perform these tests. The ferric chloride test for phenylketonuria (PKU) can yield a false positive result if iodoquinol is present in the diaper or urine. Prolonged use may result in overgrowth of non-susceptible organisms requiring appropriate therapy. Keep out of reach of children. Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of hydrocortisone or iodoquinol. In vitro studies to determine mutagenicity with hydrocortisone have revealed negative results. Mutagenicity studies have not zbeen conducted with iodoquinol.
Pregnancy Category C: Animal reproductive studies have not been conducted with Dermazene Cream. It is not known whether Dermazene Cream can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Dermazene Cream should be given to a pregnant woman only if clearly needed.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Dermazene Cream is administered to a nursing woman.
Pediatric Use: Safety and effectiveness in children under the age of 12 have not been established.
Adverse Reactions:
The following local adverse reactions are reported infrequently with topical corticosteroids. 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, Miliaria. DOSAGE AND ADMINISTRATION: Apply to
affected area 3 to 4 times daily in accordance with physician?s directions.
