PROCTOFOAM NS PRAMOXINE HYDROCHLORIDE VIATRIS SPECIALTY LLC FDA Approved Use for the temporary relief of pain and itching associated with hemorrhoids
FunFoxMeds bottle
Route
RECTAL
Applications
M346
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient Pramoxine hydrochloride 1%
Inactive Ingredients
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
Strengths
1 %
Treats Conditions
Use For The Temporary Relief Of Pain And Itching Associated With Hemorrhoids
Pill Appearance
Color: white

Identifiers & Packaging

Container Type BOTTLE
All Product Codes
UNII
88AYB867L5
Packaging

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

Package Descriptions
  • 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

Overview

Use for the temporary relief of pain and itching associated with hemorrhoids

Indications & Usage

Use for the temporary relief of pain and itching associated with hemorrhoids

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 • 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

Warnings & Precautions
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.
Purpose

Purpose Local anesthetic

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.

Questions

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..


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