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 Mayne Pharma. 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%.
Inactive Ingredients:
Cetyl alcohol, emulsifying wax, methylparaben, polyoxyethylene C12-C14 ether, PPG5 Ceteth-20, propylene glycol, propylparaben, purified water, sorbitan trioleate, trolamine, and inert propellant: tetrafluoroethane.
Indication:
Use for the temporary relief of pain and itching associated with hemorrhoids.
Directions: Shake Well Before Use.
Dispense Pramoxine Hydrochloride 1% onto a clean tissue or pad and apply externally to the affected area up to 5 times daily. See carton for additional directions for use.
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. Certain persons can develop allergic reactions to 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 immediately and consult a physician. Do not use in the eyes or nose. Do not apply to large areas of the body.
Caution: For External Use Only.
Do not insert any part of the aerosol container into the rectum. Contents of the container are under pressure. Do not burn or puncture the aerosol container. Do not store at temperatures above 49°C (120°F).
STORE UPRIGHT AT CONTROLLED ROOM TEMPERATURE 20°-25°C (68°-77°F). DO NOT REFRIGERATE.
Otc - Keep Out Of Reach Of Children
Keep this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
Other
Distributed by:
Mayne Pharma
Greenville, NC 27834
Net Wt. 0.53 oz (15 g)
HOLD UPRIGHT TO DISPENSE
Principal Display Panel - 15 G Container Carton
NDC 51862-180-15
Pramoxine
Hydrochloride 1%
For external use only
Hemorrhoidal Foam-Non Steroid
SHAKE WELL BEFORE USING
Net Wt. 0.53 oz. (15 g)
Foam
maynepharma
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