FDA Label for Pramoxine Hydrochloride
View Indications, Usage & Precautions
Pramoxine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Physicians Total Care, Inc.. 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.
Active Ingredient
Pramoxine hydrochloride 1%
Purpose
Local Anesthetic
Use
for the temporary relief of pain and itching associated with hemorrhoids
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 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).
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.
Questions?
1-888-317-0001
Principal Display Panel - 15 G Carton
NDC 54868-5865-0
STORE UPRIGHT
proctofoam®
non-
steroid
(pramoxine hydrochloride 1%)
hemorrhoidal foam
For temporary
relief of
hemorrhoidal
pain and itching
For External Use Only
15 g net wt (0.53 oz)
* Please review the disclaimer below.