Pramoxine Hydrochloride And Hydrocortisone Acetate

INDICATIONS AND USAGE Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-877-848-6610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 approximately 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

Pregnancy 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 of 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.

WARNINGS Not for prolonged use. If redness, pain, irritation or swelling persists, discontinue use and consult a physician. Contents of the container are under pressure. Do not burn or puncture the aerosol container. Do not store at temperatures above 120°F (49°C). Keep this and all medicines out of the reach of children. CONTRAINDICATIONS Topical corticosteroid products are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.