LIDOCAINE HYDROCHLORIDE, EPINEPHRINE HYDROCHLORIDE

FDA Drug Profile — GOLD LABEL B NUMB, THE SOLUTION

Drug Details

Generic Name
LIDOCAINE HYDROCHLORIDE, EPINEPHRINE HYDROCHLORIDE
Brand Names
GOLD LABEL B NUMB, THE SOLUTION
Application Number
M015
Sponsor
SCALP TECH INC
NDC Codes
2
Dosage Forms
SPRAY
Routes
TOPICAL
Active Ingredients
EPINEPHRINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

Indications and Usage

USES TEMPORARILY RELIEVES SYMPTOMS DUE TO HEMORRHOIDS, HEMORRHOIDAL TISSUES OR PILES: ITCHING PAIN SORENESS BURNING

Warnings

WARNINGS FOR EXTERNAL USE ONLY. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU HAVE HEART DISEASE HIGH BLOOD PLESSURE THYROID DISEASE DIABETES DIFFICULTY IN URINATION TAKE MEDICINE FOR HIGH BLOOD PRESSURE DEPRESSION WHEN USING THIS PRODUCT DO NOT PUT 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 REDNESS, IRRITATION, SWELLING, PAIN OR OTHER SYMPTOMS OCCUR YOU EXPERIENCE WEAKNESS CONFUSION HEADACHE DIFFICULTY BREATHING PALE, GREY OR BLUE COLOURED SKIN. THESE MIGHT BE SIGNS OF METHEMOGLOBINEMIA, A RARE DISORDER, WHICH MAY APPEAR UP TO 2 HOURS AFTER USE.