The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredient Pramoxine hydrochloride 1%
Otc - Purpose
Indications & Usage
Use for the temporary relief of pain and itching associated with hemorrhoids
Warnings Do not exceed the recommended daily dosage unless directed by a physician.If condition worsens or does not improve within 7 days, consult a physician.In case of rectal bleeding, consult a physician promptly.Do not put this product into the rectum by using fingers or any mechanical device or applicator. Do not insert any part of the aerosol container into the rectum.Certain persons can develop allergic reactions to the ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a physician.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
- DirectionsPlace cap on container. Shake well before use.Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.Gently dry by patting or blotting with toilet tissue or a soft cloth before application of proctofoam®.Dispense proctofoam®. onto a clean tissue and apply externally to the affected area up to 5 times daily.Children under 12 years of age: consult a physician.
- Other informationStore upright at controlled room temperature 20° - 25°C (68° - 77°F); excursions permitted between 15° - 30°C (59° - 86°F).Do not refrigerate.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).
Meda Pharmaceuticals Inc.
Somerset, New Jersey 08873-4120
©2013 Meda Pharmaceuticals Inc.
PROCTOFOAM and MEDA PHARMACEUTICALS are registered trademarks of Meda AB or a related entity.Rev. 7/2013
Inactive ingredientscetyl alcohol, glyceryl monostearate and PEG-100 stearate blend, methylparaben, polyoxyethylene 23 lauryl ether, polyoxyl 40 stearate, propylene glycol, propylparaben, purified water, trolamine and inert propellants: isobutane and propane.
Otc - Questions
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