FDA Label for Proctofoam NS
View Indications, Usage & Precautions
Proctofoam NS Product Label
The following document was submitted to the FDA by the labeler of this product Meda Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredient
Pramoxine hydrochloride 1%
Otc - Purpose
Purpose
Local Anesthetic
Indications & Usage
Use
for the temporary relief of pain and itching associated with hemorrhoids
Warnings
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
Directions
- Place 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
Other information
- Store 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).
Distributed by:
MEDA
Pharmaceuticals®
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 Ingredient
Inactive ingredients
cetyl 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
Questions?
1-888-350-1908
Package Label.Principal Display Panel
PRINCIPAL DISPLAY PANEL – 15 g CARTON
NDC 0037-6823-15
STORE UPRIGHT
proctofoam® non-steroid
(pramoxine hydrochloride 1%)
hemorrhoidal foam
For temporary
relief of
hemorrhoidal
pain and itching
For External Use Only
MEDA
PHARMACEUTICALS®
15 g net wt (0.53 oz)
* Please review the disclaimer below.