Urea Hydrating Topical
Urea
Acella Pharmaceuticals
Human Prescription Drug
NDC 42192-115Urea Hydrating Topical also known as Urea is a human prescription drug labeled by 'Acella Pharmaceuticals'. National Drug Code (NDC) number for Urea Hydrating Topical is 42192-115. This drug is available in dosage form of Aerosol, Foam. The names of the active, medicinal ingredients in Urea Hydrating Topical drug includes Urea - 35 g/100g . The currest status of Urea Hydrating Topical drug is Active.
Drug Information:
| Drug NDC: | 42192-115 |
| 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: | Urea Hydrating Topical |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| 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 |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Acella 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: | UREA - 35 g/100g
|
| 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: | 21 May, 2010 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 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: | Acella Pharmaceuticals
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 849646
|
| 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 |
|---|
| 42192-115-15 | 150 g in 1 CANISTER (42192-115-15) | 21 May, 2010 | 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:
Urea hydrating topical urea dimethicone ethylparaben glycerin lactic acid methylparaben phenoxyethanol polysorbate 20 povidone propylene glycol propylparaben water stearic acid trolamine butane propane urea urea
Indications and Usage:
Indications and usage for enzymatic debridement and promotion of normal healing of surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris, or eschar. topically applied urea is useful for the treatment of hyperkeratotic conditions such as dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis, keratoderma, and dry, rough skin, as well as corns and calluses and damaged, ingrown and devitalized nails.
Warnings:
Warnings urea 35% hydrating topical foam is for external use only. it is not for ophthalmic, oral, anal or intravaginal use. contact with eyes, lips, and all mucous membranes should be avoided. urea 35% hydrating topical foam should not be used by persons who have a known hypersensitivity to urea or any of the other listed ingredients.
Dosage and Administration:
Dosage and administration unless otherwise directed by a prescribing physician, urea 35% hydrating topical foam should be applied to affected area twice a day. urea 35% hydrating topical foam should be rubbed into the skin until it is completely absorbed.
Contraindications:
Contraindications known hypersensitivity to any of the listed ingredients.
Adverse Reactions:
Adverse reactions transient stinging, burning, itching or irritation is possible.
Use in Pregnancy:
Pregnancy (category b) â animal reproduction studies have not been performed with topically applied urea and it is not known whether urea 35% hydrating topical foam can cause fetal harm when administered to a pregnant woman. nevertheless, urea 35% hydrating topical foam should be used by a pregnant woman only if necessary.
Description:
Description urea 35% hydrating topical foam is a keratolytic emollient in a water and lipid based foam containing lactic acid which is a gentle, but potent, tissue softener for skin and nails. each gram of urea 35% hydrating topical foam contains urea 35% as the active ingredient, and the following inactive ingredients: dimethicone, ethylparaben, glycerin, lactic acid, methylparaben, phenoxyethanol, polysorbate 20, povidone, propylene glycol, propylparaben, purified water, stearic acid, trolamine, and in propellants butane and propane. chemical structure urea has the following chemical structure: ureachemformula
Clinical Pharmacology:
Clinical pharmacology topically applied urea dissolves the intercellular matrix of the skin which results in enhanced shedding of scaly, dry skin and thus a softening of the hyperkeratotic areas of the skin. urea topically applied to the nail plate has a similar effect on the intercellular matrix of the nail plate.
Pharmacokinetics:
Pharmacokinetics the mechanism of action of topically applied urea is not yet known.
How Supplied:
How supplied urea 35% hydrating topical foam is supplied in a 150 gram or 5.3 ounce aerosolized canister bearing the ndc number 42192-115-15.
Package Label Principal Display Panel:
Productlabel
Ndc 42192-115-15 urea 35% hydrating topical foam rx only net wt. 5.3 oz. (150 g) ndc 42192-115-15 rx only net wt. 5.3 oz. (150 g) dosage and administration: clean and dry affected skin. then apply urea 35% hydrating topical foam topically to cover affected skin twice per day, or as directed by a physician. rub in until completely absorbed. shake vigorously before each application and invert can to administer. store at room temperature 59° - 77°f (15° - 25°c). see prescribing information for additional details. ingredients: urea 35%, dimethicone, ethylparaben, glycerin, lactic acid, methylparaben, phenoxyethanol, polysorbate 20, povidone, propylene glycol, propylparaben, purified water, stearic acid, trolamine, and in propellants butane and propane. warning: contents under pressure. do not puncture or incinerate. do not expose to temperatures over 120°f (48°c) even when empty. keep out of reach of children. manufactured for: acella pharmaceuticals, llc alpharetta, ga 30009 1-800-541-4802 1 2