Proctofoam Aerosol, Foam
FDA Label NDC 0037-6823

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Viatris Specialty Llc for the product Proctofoam (NDC 0037-6823). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient

Pramoxine hydrochloride 1%

 

Otc - Purpose

Purpose

Local Anesthetic

 

Indications & Usage

Use

for the temporary relief of pain and itching associated with hemorrhoids

 

Warnings

Warnings

Do not exceed the recommended daily dosage unless directed by a physician.

If condition worsens or does not improve within 7 days, consult a physician.

In case of rectal bleeding, consult a physician promptly.

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.

Certain persons can develop allergic reactions to the ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a physician.

Otc - Keep Out Of Reach Of Children

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

 

Dosage & Administration

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 of proctofoam®.
  • Dispense proctofoam®. 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.

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Other

Other information

  • Store upright at controlled room temperature 20° - 25°C (68° - 77°F); excursions permitted between 15° - 30°C (59° - 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 120°F (49°C).

    •  

    Distributed by:
    MEDA
    Pharmaceuticals®
    Meda Pharmaceuticals Inc.
    Somerset, New Jersey 08873-4120
    ©2013 Meda Pharmaceuticals Inc.

    PROCTOFOAM and MEDA PHARMACEUTICALS are registered trademarks of Meda AB or a related entity.

    Rev. 7/2013

     

Inactive Ingredient

Inactive ingredients

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

 

Otc - Questions

Questions?

1-888-350-1908

Package Label.Principal Display Panel

PRINCIPAL DISPLAY PANEL – 15 g CARTON

NDC 0037-6823-15

STORE UPRIGHT

proctofoam® non-steroid

(pramoxine hydrochloride 1%)

hemorrhoidal foam

For temporary
relief of
hemorrhoidal
pain and itching

For External Use Only

MEDA
PHARMACEUTICALS®

15 g net wt (0.53 oz)

* Please review the disclaimer below.