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FDA LABEL GENERIC: Pramoxine MFR: Viatris Specialty LLC

Proctofoam 1 % Rectal Foam

Pramoxine hydrochloride 1%

Local anesthetic

INDICATIONS AND USAGE

for 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.

DOSAGE AND ADMINISTRATION

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
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)

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

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..

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

Use for 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