cocoa butter, phenylephrine hydrochloride, and witch hazel

FDA Drug Profile — Preparation H

Drug Details

Generic Name
cocoa butter, phenylephrine hydrochloride, and witch hazel
Brand Names
Preparation H
Application Number
M015
Sponsor
Haleon US Holdings LLC
NDC Codes
1
Dosage Forms
KIT
Routes
N/A
Active Ingredients
N/A

Indications and Usage

Uses helps relieve the local itching and discomfort associated with hemorrhoids temporarily relieves burning and shrinks hemorrhoidal tissue temporarily provides a coating for relief of anorectal discomforts temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful Uses helps relieve the local itching and discomfort associated with hemorrhoids temporary relief of irritation and burning aids in protecting irritated anorectal areas

Warnings

Warnings For rectal use only Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes difficulty in urination due to enlargement of the prostate gland 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 exceed the recommended daily dosage unless directed by a doctor Stop use and ask a doctor if bleeding occurs condition worsens or does not improve within 7 days 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. Warnings For external use only When using this product 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 condition worsens or does not improve within 7 days 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.