Lidocaine , Phenylephrine Hcl

FDA Drug Profile — Liposomal Hemorrhoid Master

Drug Details

Generic Name
Lidocaine , Phenylephrine Hcl
Brand Names
Liposomal Hemorrhoid Master
Application Number
M015
Sponsor
Clinical Resolution Laboratory, Inc.
NDC Codes
1
Dosage Forms
CREAM
Routes
TOPICAL
Active Ingredients
LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE

Indications and Usage

Uses: For the temporary relief of local and anorectal itching and discomfort associated with anorectal disorders and anorectal inflammation For the temporary relief of pain, burning and soreness. Temporarily shrinks hemorrhoidal tissue Temporarily reduces the swelling associated with irritation in hemorrhoids and other anorectal disorders.

Warnings

Warnings For external and / or intrarectal use only. If condition worsens or does not improve within 7 days, consult a doctor. Do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, consult a doctor promptly. 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 and consult a doctor. Do not use this product if you have heart disease, high blood pressure, thyroid disease, diabetes or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor. Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression. Do not use this product with an applicator if the introduction of the applicator into the rectum causes additional pain. Consult a doctor promptly.