OTHER SAFETY INFORMATION.


Other information. ostore upright at controlled room temperature 20 to 25C (68 to 77F); excursions permitted between 15 to 30C (59 to 86F)odo not refrigerateocontents of the container are under pressure. Do not burn or puncture the aerosol containerodo not store at temperatures above 49C (120F). ostore upright at controlled room temperature 20 to 25C (68 to 77F); excursions permitted between 15 to 30C (59 to 86F). odo not refrigerate. ocontents of the container are under pressure. Do not burn or puncture the aerosol container. odo not store at temperatures above 49C (120F).

OTC - ACTIVE INGREDIENT SECTION.


Active ingredient. Pramoxine hydrochloride 1%.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION.


Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

OTC - PURPOSE SECTION.


Purpose. Local anesthetic.

DOSAGE & ADMINISTRATION SECTION.


Directions. oplace cap on container. Shake well before useoadults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughlyogently dry by patting or blotting with toilet tissue or soft cloth before applicationodispense onto clean tissue and apply externally to the affected area up to times dailyochildren under 12 years of age: consult physician. oplace cap on container. Shake well before use. oadults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. ogently dry by patting or blotting with toilet tissue or soft cloth before application. odispense onto clean tissue and apply externally to the affected area up to times daily. ochildren under 12 years of age: consult physician.

INACTIVE INGREDIENT SECTION.


Inactive ingredients. cetyl alcohol, glyceryl monostearate PEG-100 stearate blend, isobutane, methylparaben, polyoxyethylene 23 lauryl ether, polyoxyl 40 stearate, propane, propylene glycol, propylparaben, purified water, trolamine.

INDICATIONS & USAGE SECTION.


Use. for the temporary relief of pain and itching associated with hemorrhoids.

OTC - QUESTIONS SECTION.


Questions. 1-888-350-1908 Distributed by: Meda Pharmaceuticals Inc. Somerset, New Jersey 08873-4120(C) 2021 Viatris Inc.PROCTOFOAM is registered trademark of Alaven Pharmaceutical LLC, Viatris Company.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


Principal Display Panel 1% NDC 0037-6823-15TAMPER EVIDENT FEATURE: Do not use if Meda Pharmaceuticals(R) seal on ends of carton are broken or missing.proctofoam(R) non-steroid pramoxine hydrochloride 1%hemorrhoidal foamFor temporaryrelief ofhemorrhoidalpain and itchingSTOREUPRIGHTNET WT.0.53 OZ (15 g). Proctofoam Foam 1% Carton Label.

SPL UNCLASSIFIED SECTION.


When using this product odo not exceed the recommended daily dosage unless directed by doctorodo not put this product into the rectum by using fingers or any mechanical device or applicatorodo not insert any part of the aerosol container into the rectum. odo not exceed the recommended daily dosage unless directed by doctor. odo not put this product into the rectum by using fingers or any mechanical device or applicator. odo not insert any part of the aerosol container into the rectum.

WARNINGS SECTION.


Warnings. For external use only. When using this product odo not exceed the recommended daily dosage unless directed by doctorodo not put this product into the rectum by using fingers or any mechanical device or applicatorodo not insert any part of the aerosol container into the rectum. odo not exceed the recommended daily dosage unless directed by doctor. odo not put this product into the rectum by using fingers or any mechanical device or applicator. odo not insert any part of the aerosol container into the rectum. Stop use and ask doctor if orectal bleeding occursocondition worsens or does not improve within daysoallergic reaction occurs to the ingredients in this productosymptom being treated does not subsideoredness, irritation, swelling, pain or other symptoms develop or increase. orectal bleeding occurs. ocondition worsens or does not improve within days. oallergic reaction occurs to the ingredients in this product. osymptom being treated does not subside. oredness, irritation, swelling, pain or other symptoms develop or increase. If pregnant or breast-feeding, ask health professional before use.. Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.