Pramoxine Hydrochloride
FDA Label NDC 54868-5865

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Physicians Total Care, Inc. for the product Pramoxine Hydrochloride (NDC 54868-5865). 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 active ingredient, purpose, use, directions, other information, inactive ingredients, questions?, principal display panel - 15 g carton, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Pramoxine hydrochloride 1%

Purpose

Local Anesthetic

Use

for the temporary relief of pain and itching associated with hemorrhoids

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.

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).

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.

Questions?

1-888-317-0001

Principal Display Panel - 15 G Carton

NDC 54868-5865-0

Principal Display Panel (15 g Carton)

Principal Display Panel (15 g Carton)


STORE UPRIGHT

proctofoam®
non-
steroid
(pramoxine hydrochloride 1%)

hemorrhoidal foam

For temporary
relief of
hemorrhoidal
pain and itching

For External Use Only

15 g net wt (0.53 oz)

* Please review the disclaimer below.