PROCTOFOAM
Drug Facts
cddc8d81-21b8-11e4-8c21-0800200c9a66
HUMAN OTC DRUG LABEL
Aug 15, 2025
Viatris Specialty LLC
DUNS: 117455616
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
pramoxine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (13)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal Display Panel – 1%
NDC 0037-6823-15
TAMPER EVIDENT FEATURE: Do not use if Meda Pharmaceuticals® seal on ends of carton are broken or missing.
proctofoam**®**** non-steroid**
****pramoxine hydrochloride 1%
hemorrhoidal foam
For temporary
relief of
hemorrhoidal
pain and itching
STORE
UPRIGHT
NET WT.
0.53 OZ (15 g)
Drug Facts
Active ingredient Purpose
Pramoxine hydrochloride 1%. . . . . . . . Local anesthetic
Usefor the temporary relief of pain and itching
associated with hemorrhoids
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
•
do not insert any part of the aerosol container into the rectum
Stop use and ask a doctor if
•
rectal bleeding occurs
•
condition worsens or does not improve within 7 days
•
allergic reaction occurs to the ingredients in this product
•
symptom being treated does not subside
•
redness, irritation, swelling, pain or other symptoms develop or increase
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.
Directions
•
place cap on container. Shake well before use
•
adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
•
gently dry by patting or blotting with toilet tissue or a soft cloth before application
•
dispense onto a clean tissue and apply externally to the affected area up to 5 times daily
•
children under 12 years of age: consult a physician
Drug Facts (continued)
Other information
•
store upright at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F)
•
do not refrigerate
•
contents of the container are under pressure. Do not burn or puncture the aerosol container
•
do not store at temperatures above 49°C (120°F)
Drug Facts (continued)
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
Questions? 1-888-350-1908
Distributed by:
MEDA PHARMACEUTICALS**®**
Canonsburg, PA 15317 U.S.A.
©2025 Viatris Inc.
PROCTOFOAM is a
registered trademark of
Alaven Pharmaceutical LLC,
a Viatris Company.
117789
UC-82315-15-05
INDICATIONS & USAGE SECTION
Use
for the temporary relief of pain and itching associated with hemorrhoids
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Pramoxine hydrochloride 1%
OTC - PURPOSE SECTION
Purpose
Local anesthetic
WARNINGS SECTION
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
•
do not insert any part of the aerosol container into the rectum
Stop use and ask a doctor if
•
rectal bleeding occurs
•
condition worsens or does not improve within 7 days
•
allergic reaction occurs to the ingredients in this product
•
symptom being treated does not subside
•
redness, irritation, swelling, pain or other symptoms develop or increase
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.
DOSAGE & ADMINISTRATION SECTION
Directions
•
place cap on container. Shake well before use
•
adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
•
gently dry by patting or blotting with toilet tissue or a soft cloth before application
•
dispense onto a clean tissue and apply externally to the affected area up to 5 times daily
•
children under 12 years of age: consult a physician
OTHER SAFETY INFORMATION
Other information
•
store upright at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F)
•
do not refrigerate
•
contents of the container are under pressure. Do not burn or puncture the aerosol container
•
do not store at temperatures above 49°C (120°F)
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
OTC - QUESTIONS SECTION
Questions?
1-888-350-1908
Distributed by:
Meda Pharmaceuticals Inc.
****Canonsburg, PA 15317 U.S.A.
© 2025 Viatris Inc.
PROCTOFOAM is a registered trademark of Alaven Pharmaceutical LLC, a Viatris Company..