Lidocaine 4.00, Phenylephrine Hydrochloride 0.25

FDA Drug Profile — Dr Butlers Hemorrhoid and Fissure PF

Drug Details

Generic Name
Lidocaine 4.00, Phenylephrine Hydrochloride 0.25
Brand Names
Dr Butlers Hemorrhoid and Fissure PF
Application Number
M015
Sponsor
Beyond Health P.A.
NDC Codes
1
Dosage Forms
OINTMENT
Routes
TOPICAL
Active Ingredients
LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE

Indications and Usage

Uses temporarily shrinks hemorrhoidal tissue for the temporary relief of pain, soreness, or burning helps relieve the local itching and discomfort associated with hemorrhoids

Warnings

Warnings For external use only including the skin of the anal canal. When using this product do not exceed recommended dosage unless directed by a doctor when using finger cots or an applicator, apply externally or to the skin of the anal canal only. Do not put this product into the rectum Ask a doctor before use if you have allergies to any of the components of this product difficulty in urination due to enlargement of the prostate gland Diabetes Heart Disease High Blood Pressure Thyroid Disease presently taking a prescription for high blood pressure or depression Stop use and ask a doctor if condition worsens or does not improve within seven (7) days bleeding occurs an allergic reation develops the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase If pregnant or breast-feeding as a health care professional before use. Keep out of reach of children if swallowed, seek medical help or contact a Poison Control Center right away.