Umecta Mousse Urea
Urea Foam
Epi Health, Inc
Human Prescription Drug
NDC 71403-020Umecta Mousse Urea also known as Urea Foam is a human prescription drug labeled by 'Epi Health, Inc'. National Drug Code (NDC) number for Umecta Mousse Urea is 71403-020. This drug is available in dosage form of Aerosol, Foam. The names of the active, medicinal ingredients in Umecta Mousse Urea drug includes Urea - 400 mg/g . The currest status of Umecta Mousse Urea drug is Active.
Drug Information:
| Drug NDC: | 71403-020 |
| 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: | Umecta Mousse Urea |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Umecta Mousse |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Urea |
| 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 Prescription 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: | Urea Foam |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Epi Health, Inc |
| 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: | UREA - 400 mg/g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| 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: | UNAPPROVED DRUG OTHER |
| 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: | 01 Sep, 2007 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 25 Jun, 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. |
| 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: | EPI Health, Inc
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 700903
748312
|
| 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: | 8W8T17847W
|
| 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 |
|---|
| 71403-020-01 | 113.4 g in 1 CAN (71403-020-01) | 01 Sep, 2007 | 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. |
Product Elements:
Umecta mousse urea urea foam urea urea butane shea butter carbomer homopolymer type b (allyl sucrose crosslinked) soybean oil sunflower oil isobutane laureth-4 polysorbate 20 propane water stearic acid trolamine
Indications and Usage:
Indications and usage for debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eschar. urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis, keratoderma, corns, and calluses, as well as damaged, ingrown and devitalized nails.
Warnings:
Warnings for external use only. avoid contact with eyes, lips or mucous membranes. umecta mousse canister - contents under pressure do not puncture or incinerate. do not store at temperatures above 120º f.
Dosage and Administration:
Dosage and administration apply umecta pd bioadhesive emulsion/topical suspension or umecta mousse to affected skin twice per day, or as directed by a physician. rub in until completely absorbed
Contraindications:
Contraindications known hypersensitivity to any of the listed ingredients.
Adverse Reactions:
Adverse reactions transient stinging, burning, itching, or irritation may occur and normally disappear on discontinuing the medication.
Use in Pregnancy:
Pregnancy animal reproduction studies have not been conducted with umecta. it is also not known whether umecta can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. umecta should be given to a pregnant woman only if clearly needed.
Description:
Description rx only for topical use only not for ophthalmic use umecta is a keratolytic, emollient which is a gentle, yet potent, tissue softener for nails and skin each gram of umecta mousse contains urea (40%), butane, butyrospermum parkii (shea butter) extract, carbomer, glycine soya (soy bean) sterol, helianthus annuus (sunflower) oil, isobutane, laureth-4, polysorbate-20, propane, purified water, stearic acid, triethanolamine. urea is a diamide of carbonic acid with the following chemical structure: image of chemical structure
Clinical Pharmacology:
Clinical pharmacology urea gently dissolves the intercellular matrix which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas. urea also hydrates and gently dissolves the intercellular matrix of the nail plate which can result in the softening and eventual debridement of the nail plate.
Pharmacokinetics:
Pharmacokinetics the mechanism of action of topically applied urea is not yet known.
How Supplied:
How supplied umecta (urea, 40%) mousse is available in a: 4 oz. can ndc 68712-020-01 store at controlled room temperature 15-30°c (59-86°f). protect from freezing. manufactured for: innocutis holdings llc charleston, sc 29401 toll free: 1-800-499-4468 www.innocutis.com www.umecta.com
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