Phenylephrine Hydrochloride, Pramoxine Hydrochloride, Glycerin, Petrolatum

FDA Drug Profile — Signature Care Hemorrhoidal Cream (with applicator)

Drug Details

Generic Name
Phenylephrine Hydrochloride, Pramoxine Hydrochloride, Glycerin, Petrolatum
Brand Names
Signature Care Hemorrhoidal Cream (with applicator)
Application Number
M015
Sponsor
BETTER LIVING BRANDS, LLC
NDC Codes
1
Dosage Forms
CREAM
Routes
TOPICAL
Active Ingredients
GLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE

Indications and Usage

Directions adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying cream. when first opening the tube, peel back foil seal apply externally or in the lower portion of the anal canal only apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement for application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube. Lubricate dispensing cap well, then gently insert dispensing cap partway into the anus thoroughly cleanse dispensing cap after each use and replace cover children under 12 years of age: ask a doctor

Warnings

Warnings For external and/or intrarectal use only