Glycerin, Petrolatum, Phenylephrine hydrochloride, and Pramoxine hydrochloride

FDA Drug Profile — Nikzon Hemorrhoidal

Drug Details

Generic Name
Glycerin, Petrolatum, Phenylephrine hydrochloride, and Pramoxine hydrochloride
Brand Names
Nikzon Hemorrhoidal
Application Number
M015
Sponsor
Genomma Lab USA
NDC Codes
1
Dosage Forms
CREAM
Routes
TOPICAL
Active Ingredients
GLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE

Indications and Usage

Uses for the temporary relief of anorectal itching and discomfort associated with hemorrhoids, anorectal disorders, inflamed hemorrhoidal tissues, or piles

Warnings

Warnings For external use only. Do not use this product in the eyes or nose 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. When using this product do not apply to large areas of the body do not exceed the recommended daily dosage unless directed by a doctor do not put this product into the rectum by using fingers or any mechanical device or applicator. Stop use and ask a doctor if bleeding occurs the condition worsens or does not improve within 7 days an allergic reaction develops the symptom being treated does not subside or redness, irritation, swelling or pain develops, persists, or increase. persists, or increases. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.