NDC 0037-6823 Proctofoam NS

Pramoxine Hydrochloride

NDC Product Code 0037-6823

NDC 0037-6823-15

Package Description: 1 CANISTER in 1 CARTON > 15 g in 1 CANISTER

NDC Product Information

Proctofoam NS with NDC 0037-6823 is a a human over the counter drug product labeled by Meda Pharmaceuticals. The generic name of Proctofoam NS is pramoxine hydrochloride. The product's dosage form is aerosol, foam and is administered via rectal form.

Labeler Name: Meda Pharmaceuticals

Dosage Form: Aerosol, Foam - A dosage form containing one or more active ingredients, surfactants, aqueous or nonaqueous liquids, and the propellants; if the propellant is in the internal (discontinuous) phase (i.e., of the oil-in-water type), a stable foam is discharged, and if the propellant is in the external (continuous) phase (i.e., of the water-in-oil type), a spray or a quick-breaking foam is discharged.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Proctofoam NS Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • PRAMOXINE HYDROCHLORIDE 150 mg/15g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • LAURETH-23 (UNII: N72LMW566G)
  • POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • ISOBUTANE (UNII: BXR49TP611)
  • PROPANE (UNII: T75W9911L6)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Rectal - Administration to the rectum.
  • Rectal - Administration to the rectum.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Meda Pharmaceuticals
Labeler Code: 0037
FDA Application Number: part346 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 08-18-2014 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Information for Patients

Pramoxine

Pramoxine is pronounced as (pra mox' een)

Why is pramoxine medication prescribed?
Pramoxine is used to temporarily relieve pain and itching from insect bites; poison ivy, poison oak, or poison sumac; minor cuts, scrapes, or burns; minor skin irritation...
[Read More]

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Proctofoam NS Product Label Images

Proctofoam NS Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Active ingredient Pramoxine hydrochloride 1%

Otc - Purpose

PurposeLocal 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

  • DirectionsPlace 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

  • Other informationStore 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 ingredientscetyl 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

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