Florexa
Eflornithine Hydrochloride
Pella Pharmaceuticals Co. Ltd
Human Prescription Drug
NDC 82160-125Florexa also known as Eflornithine Hydrochloride is a human prescription drug labeled by 'Pella Pharmaceuticals Co. Ltd'. National Drug Code (NDC) number for Florexa is 82160-125. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Florexa drug includes Eflornithine Hydrochloride - 4170 mg/30g . The currest status of Florexa drug is Active.
Drug Information:
| Drug NDC: | 82160-125 |
| 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: | Florexa |
| 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: | Eflornithine Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Pella Pharmaceuticals Co. Ltd |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| 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: | EFLORNITHINE HYDROCHLORIDE - 4170 mg/30g
|
| 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: | 09 Feb, 2012 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 31 Dec, 2025 |
| 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: | Pella Pharmaceuticals Co. Ltd
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 4NH22NDW9H
|
| 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. |
| Pharmacologic Class: | Antiprotozoal [EPC]
Decarboxylase Inhibitor [EPC]
Decarboxylase Inhibitors [MoA]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 82160-125-01 | 1 TUBE in 1 CARTON (82160-125-01) / 30 g in 1 TUBE | 09 Feb, 2012 | 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:
Florexa eflornithine hydrochloride eflornithine hydrochloride eflornithine eflornithine hydrochloride anhydrous
Drug Interactions:
Drug interactions it is not known if eflornithine hcl has any interaction with other topically applied drug products.
Indications and Usage:
Indications florexa is indicated for the reduction of unwanted facial hair in women. florexa has only been studied on the face and adjacent involved areas under the chin of affected individuals. usage should be limited to these areas of involvement.
Warnings:
Warnings discontinue use if hypersensitivity occurs.
General Precautions:
This is a medicament medicament is a product which affects your health and its consumption contrary to instructions is dangerous for you. strictly follow the doctor's prescription, the method of use and the instruction of the pharmacist who sold the medicament. the doctor and the pharmacist are experts in medicine, its benefits and risks. do not by yourself interrupt the period of treatment prescribed for you. do not repeat the same prescription without consulting your doctor. keep medicament out of reach of children.
Dosage and Administration:
Dosage and administration apply a thin layer of florexa , to wanted areas of the face and adjacent involved areas under the chin and rub in thoroughly. do not wash treated area for at least 4 hours. use twice daily at least 8 hours apart or as directed by a physician. the patient should continue to use hair removal techniques as needed in conjunction with florexa . ( florexa should be applied at least 5 minutes after hair removal.) cosmetics or sunscreens may be applied over treated areas; you should wait a few minutes to allow the treatment to be absorbed. florexa doesn't permanently remove hair or "cure" unwanted facial hair. it is not a depilatory. your treatment program should include continuation of any hair removal technique you are currently using. florexa will help you manage your condition and improve your appearance. improvement in the condition occurs gradually. don't be discouraged if you see no immediate improvement. be patient. improvement may be seen as early as 4 to 8 w
Read more...eeks of treatment. improvement may take longer in some individuals. if no improvement is seen after 6 months of use; discontinue use.
Contraindications:
Contraindications eflomithine hcl is contraindicated in patients with a history of sensitivity to any components of the preparation. children less than 12 years of age shouldn't use florexa .
Adverse Reactions:
Side effects the following side effects have been reported acne, pseudofolliculitis barbae, stinging skin, headache, burning skin, dry skin, pruritus (itching), erythema (redness), tingling skin, dyspepsia, skin irritation, rash, alopecia, dizziness, folliculitis, hair ingrown, facial edema, anorexia, nausea, asthenia, vertigo.
Drug Interactions:
Drug interactions it is not known if eflornithine hcl has any interaction with other topically applied drug products.
Use in Pregnancy:
Pregnancy because there are no adequate and well-controlled studies in pregnant women, the risk / benefit ratio of using eflornithine hcl in women with unwanted facial hair who are pregnant should be weighed carefully with serious consideration for either not implementing or discontinuing use of florexa .
Overdosage:
Overdosage overdosage information is unavailable.
Description:
Properties florexa is a prescribed medication applied to the skin for the reduction of unwanted facial hair in women. there are no studies examining the inhibition of the enzyme ornithine decarboxylase (odc) in human skin following the application of topical eflornithine. however, there are studies in the literature that report the inhibition of odc activity in skin following oral eflornithine. it is postulated that topical eflornithine hydrochloride irreversibly inhibits skin odc activity. this enzyme is necessary in the synthesis of polyamines. animal data indicate that inhibition of ornithine decarboxylase inhibits cell division and synthetic functions, which affect the rate of hair growth. eflornithine hydrochloride cream 13.9% has been shown to retard the rate of hair growth in non-clinical and clinical studies.
How Supplied:
How supplied 30 g packs
Package Label Principal Display Panel:
Primary package primary package
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