Hydrocortisone 1%-Iodoquinol 1% Cream

Rx Only

Each gram of Hydrocortisone 1%−Iodoquinol 1% Cream contains 10 mg of hydrocortisone and 10 mg of iodoquinol in a greaseless base of cetyl alcohol, glyceryl monostearate SE, isopropyl myristate, lanolin alcohol, mineral oil, polyoxyl 40 stearate, polysorbate 20, polysorbate 60, propylene glycol, purified water, sorbic acid, and sorbitan monostearate. Paraben free.

Chemically, hydrocortisone is [Pregn-4-ene-3,20-dione, 11, 17, 21- trihydroxy-,(11ß)-] with the molecular formula C₂₁H₃₀O₅ and is represented by the following structural formula:

and iodoquinol, 5,7-diiodo-8-quinolinol (C₉H₅I₂NO) is represented by the following structure:

Hydrocortisone is an anti-inflammatory and antipruritic agent, while iodoquinol is an antifungal and antibacterial agent.

Hydrocortisone has anti-inflammatory, antipruritic and vasoconstrictor properties. The mechanism of anti-inflammatory activity is unclear. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

Iodoquinol has both antifungal and antibacterial properties.

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.

Hydrocortisone 1%−Iodoquinol 1% Cream is contraindicated in those patients with a history of hypersensitivity to hydrocortisone, iodoquinol or any other components of the preparation.

FOR EXTERNAL USE ONLY. Keep away from eyes. Keep out of reach of children. Keep tube tightly closed.

If irritation develops, the use of Hydrocortisone 1%−Iodoquinol 1% Cream should be discontinued and appropriate therapy instituted. Staining of the skin, hair 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 topical 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.

The following local adverse reactions are reported infrequently with topical corticosteroids. These reactions are listed in an approximate decreasing order of occurrence:

Burning

Perioral dermatitis

Itching

Allergic contact dermatitis

Irritation

Maceration of the skin

Dryness

Secondary infection

Folliculitis

Skin atrophy

Hypertrichosis

Striae

Acneiform eruptions

Miliaria

Hypopigmentation

Apply to affected area 3 to 4 times daily in accordance with physician’s directions.

Hydrocortisone 1%−Iodoquinol 1% Cream is available as follows:

1 oz. tube (NDC 45802-930-64)

Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Keep tightly closed.

Manufactured by Perrigo

Bronx, NY 10457

Distributed By

Perrigo®

Allegan, MI 49010 ● www.perrigo.com

Rev. 11/11

3J700 RC J2

Rx Only

Hydrocortisone 1% - Iodoquinol 1% Cream

NET WT 1 OZ (28.4 g)

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