pramoxine/hydrocortisone - topical, Enzone, Pramosone (cont.)
HOW TO USE: Before applying the medication, clean the affected area with mild soap and water, rinse well, and pat dry. Gently rub a small amount of the medication into the affected area and surrounding skin in a thin layer, usually 3-4 times a day or as directed by your doctor. How often the medication is applied and for how long depends on your condition and response to treatment.Wash hands immediately after use unless the area being treated includes the hands. Avoid getting the product in your eyes, nose, ears, or mouth. If the medication gets in these areas, rinse immediately with clean water.Do not cover the area with waterproof bandages or plastic, apply heat, or use the product on large areas of the body unless directed to do so by your doctor. If used in the diaper area on an infant, do not use tight-fitting diapers or plastic pants. These may increase the risk of side effects.Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day.Do not use more of this product, use it more often, or keep using it longer than prescribed by your doctor. If you have been using this medication for a long time or in high doses, do not suddenly stop using it without your doctor's approval. Some conditions may become worse when this drug is suddenly stopped. Your dose may need to be gradually decreased.Inform your doctor if your condition does not improve or if it worsens.
SIDE EFFECTS: Redness, burning, dryness, or itching at the application site may occur. If any of these effects persist or worsen, contact your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor immediately if any of these unlikely but serious side effects occur: change in skin appearance (e.g., color, thickness), signs of skin infection (e.g., heat, tenderness, pus).Tell your doctor immediately if any of these rare but very serious side effects occur: signs of serious infection (e.g., fever, persistent sore throat).A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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