drug facts

drug facts
SPL v6
SPL
SPL Set ID cddc8d81-21b8-11e4-8c21-0800200c9a66
Route
rectal
Published
Effective Date 2025-08-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
pramoxine (150 mg)
Inactive Ingredients
cetyl alcohol glyceryl monostearate peg-100 stearate methylparaben laureth-23 polyoxyl 40 stearate propylene glycol propylparaben water trolamine isobutane propane

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2014-08-18

Purpose

Local anesthetic

Description

Pramoxine hydrochloride 1%


Medication Information

Warnings

For external use only

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
  • 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

Description

Pramoxine hydrochloride 1%

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..

Use

for the temporary relief of pain and itching associated with hemorrhoids

Active Ingredient

Pramoxine hydrochloride 1%

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.

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


Structured Label Content

Warnings

For external use only

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
  • 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 (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 (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..

Use

for the temporary relief of pain and itching associated with hemorrhoids

Active Ingredient (Active ingredient)

Pramoxine hydrochloride 1%

When Using This Product (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 (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, (If pregnant or breast-feeding,)

ask a health professional before use.

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.

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


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