Proctofoam®

Proctofoam®
SPL v1
SPL
SPL Set ID 0494f952-de65-49d8-a8a6-5ee5abd53619
Route
RECTAL
Published
Effective Date 2012-05-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pramoxine (150 mg)
Inactive Ingredients
Cetyl Alcohol Glyceryl Monostearate Methylparaben Polyoxyl 40 Stearate Propylene Glycol Propylparaben Water Trolamine Isobutane Propane

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2008-02-22

Description

Drug Facts

Purpose

Local Anesthetic


Medication Information

Purpose

Local Anesthetic

Description

Drug Facts

Use

for the temporary relief of pain and itching associated with hemorrhoids

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

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.

Section 50567-7

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.

Section 50569-3

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.

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.
Questions?

1-888-317-0001

Active Ingredient

Pramoxine hydrochloride 1%

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.

Principal Display Panel 15 G Carton

NDC 54868-5865-0



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)


Structured Label Content

Use

for the temporary relief of pain and itching associated with hemorrhoids

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

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.

Section 50569-3 (50569-3)

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.

Purpose

Local Anesthetic

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.
Questions?

1-888-317-0001

Active Ingredient (Active ingredient)

Pramoxine hydrochloride 1%

Other Information (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 (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.

Principal Display Panel 15 G Carton (PRINCIPAL DISPLAY PANEL - 15 g Carton)

NDC 54868-5865-0



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)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)