pramoxine hydrochloride (PROCTOFOAM NS) Drug Information - Guideline Central

PROCTOFOAMNS (pramoxine hydrochloride) aerosol, foam

Viatris Specialty LLC
Viatris Specialty LLC
PROCTOFOAM
NS
pramoxine hydrochloride
PRAMOXINE HYDROCHLORIDE
PRAMOXINE
CETYL ALCOHOL
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
METHYLPARABEN
LAURETH-23
POLYOXYL 40 STEARATE
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
TROLAMINE
ISOBUTANE
PROPANE

Active ingredient

Pramoxine hydrochloride 1%

Purpose

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

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 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 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

Proctofoam Hydrochloride Foam Carton Label
Proctofoam Hydrochloride Foam Carton Label
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