Proctofoam Ns
Pramoxine Hydrochloride
Meda Pharmaceuticals
Human Otc Drug
NDC 0037-6823Proctofoam Ns also known as Pramoxine Hydrochloride is a human otc drug labeled by 'Meda Pharmaceuticals'. National Drug Code (NDC) number for Proctofoam Ns is 0037-6823. This drug is available in dosage form of Aerosol, Foam. The names of the active, medicinal ingredients in Proctofoam Ns drug includes Pramoxine Hydrochloride - 150 mg/15g . The currest status of Proctofoam Ns drug is Active.
Drug Information:
| Drug NDC: | 0037-6823 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Proctofoam Ns |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Proctofoam |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | NS |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Pramoxine Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Meda Pharmaceuticals |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Aerosol, Foam |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | PRAMOXINE HYDROCHLORIDE - 150 mg/15g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | RECTAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 18 Aug, 2014 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 02 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part346 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Meda Pharmaceuticals
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 828365
828367
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 88AYB867L5
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0037-6823-15 | 1 CANISTER in 1 CARTON (0037-6823-15) / 15 g in 1 CANISTER | 18 Aug, 2014 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose local anesthetic
Product Elements:
Proctofoam ns pramoxine hydrochloride pramoxine hydrochloride pramoxine cetyl alcohol glyceryl monostearate peg-100 stearate methylparaben laureth-23 polyoxyl 40 stearate propylene glycol propylparaben water trolamine isobutane propane
Indications and Usage:
Use for the temporary relief of pain and itching associated with hemorrhoids
Warnings:
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.
Dosage and 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
Package Label Principal Display Panel:
Principal display panel â 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) proctofoam foam 1% carton label
Further Questions:
Questions? 1-888-350-1908 distributed by: meda pharmaceuticals inc. somerset, new jersey 08873-4120 © 2021 viatris inc. proctofoam is a registered trademark of alaven pharmaceutical llc, a viatris company..