Fluoroplex

Fluorouracil

Almirall, Llc
Human Prescription Drug
NDC 16110-812

Fluoroplex also known as Fluorouracil is a human prescription drug labeled by 'Almirall, Llc'. National Drug Code (NDC) number for Fluoroplex is 16110-812. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Fluoroplex drug includes Fluorouracil - 10 mg/g . The currest status of Fluoroplex drug is Active.

Drug Information:

Drug NDC:	16110-812
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:	Fluoroplex
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:	Fluorouracil
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Almirall, Llc
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:	FLUOROURACIL - 10 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:	NDA
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:	03 Dec, 1993
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	21 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.
Application Number:	NDA016988
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:	Almirall, LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	92752 197709
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.
NUI:	N0000000233 N0000175595
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	U3P01618RT
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 MOA:	Nucleic Acid Synthesis Inhibitors [MoA]
Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`.
Pharmacologic Class EPC:	Nucleoside Metabolic Inhibitor [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class:	Nucleic Acid Synthesis Inhibitors [MoA] Nucleoside Metabolic Inhibitor [EPC]
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
16110-812-30	1 TUBE in 1 CARTON (16110-812-30) / 30 g in 1 TUBE	03 Dec, 1993	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.

Other medicines with the same generic name

Fluorouracil Cream

Fluorouracil

Cream
Mylan Pharmaceuticals Inc.
NDC: 0378-8078

Fluoroplex

Fluorouracil

Cream
Almirall, LLC
NDC: 16110-812

Fluorouracil

Injection, Solution
Accord Healthcare, Inc.
NDC: 16729-276

Fluorouracil

Injection, Solution
Sagent Pharmaceuticals
NDC: 25021-215

Carac

Fluorouracil

Cream
Bausch Health US, LLC
NDC: 0187-5200

Fluorouracil

Solution
Taro Pharmaceuticals U.S.A., Inc.
NDC: 51672-4062

Product Elements:

Fluoroplex fluorouracil fluorouracil fluorouracil benzyl alcohol isopropyl myristate mineral oil water sodium hydroxide

Indications and Usage:

Indications and usage fluoroplex cream is indicated for the topical treatment of multiple actinic (solar) keratoses.

Warnings:

Warnings there exists the potential for a delayed hypersensitivity reaction to fluorouracil. patch testing to prove hypersensitivity may be inconclusive 1 . if an occlusive dressing is used, there may be an increase in the incidence of inflammatory reactions in the adjacent normal skin. the patient should avoid prolonged exposure to sunlight or other forms of ultraviolet irradiation during treatment with fluoroplex cream, as the intensity of the reaction may be increased.

General Precautions:

General: there is a possibility of increased absorption through ulcerated or inflamed skin.

Dosage and Administration:

Dosage and administration the patient should be instructed to apply sufficient medication to cover the entire face or other affected areas. apply medication twice daily with fingertips and wash hands afterwards. a treatment period of 2-6 weeks is usually required. increasing the frequency of application and a longer period of administration with fluoroplex cream may be required on areas other than the head and neck. when fluoroplex cream is applied to keratotic skin, a response occurs with the following sequence: erythema, usually followed by scaling, tenderness, erosion, ulceration, necrosis and re-epithelization. when the inflammatory reaction reaches the erosion, ulceration and necrosis stages, the use of the drug should be terminated. responses may sometimes occur in areas which appear clinically normal. these may be sites of subclinical actinic (solar) keratosis which the medication is affecting.

Contraindications:

Contraindications fluorouracil is contraindicated in women who are or may become pregnant. this product should not be used by patients who are allergic to any of its components.

Adverse Reactions:

Adverse reactions pain, pruritus, burning, irritation, inflammation, allergic contact dermatitis and telangiectasia have been reported. occasionally, hyperpigmentation and scarring have also been reported.

Use in Pregnancy:

Pregnancy: teratogenic effects: fluorouracil may cause fetal harm when administered to a pregnant woman. fluorouracil administered parenterally has been shown to be teratogenic in mice, rats and hamsters, and embryolethal in monkeys. fluorouracil is contraindicated in women who are or may become pregnant. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Pediatric Use:

Pediatric use: safety and effectiveness in pediatric patients have not been established.

Overdosage:

Overdosage ordinarily, overdosage will not cause acute problems. if fluoroplex cream accidentally comes in contact with the eye(s), flush the eyes(s) with water or normal saline. if fluoroplex cream is accidentally ingested, induce emesis and gastric lavage. administer symptomatic and supportive care as needed.

Description:

Description fluoroplex Â® (fluorouracil) 1% topical cream is an antineoplastic/antimetabolite product for dermatological use. fluorouracil has the empirical formula c 4 h 3 fn 2 o 2 and a molecular weight of 130.08. it is sparingly soluble in water and slightly soluble in alcohol. the ph is approximately 8.5. structural formula: fluorouracil chemical name: 2,4(1h,3h)-pyrimidinedione, 5-fluoro-. fluoroplex 1% topical cream contains: active ingredient: fluorouracil 1.0% inactive ingredients: benzyl alcohol, emulsifying wax, isopropyl myristate, mineral oil, purified water, and sodium hydroxide. chemical structure

Clinical Pharmacology:

Clinical pharmacology there is evidence that fluorouracil (or its metabolites) blocks the methylation reaction of deoxyuridylic acid to thymidylic acid. in this fashion, fluorouracil interferes with the synthesis of deoxyribonucleic acid (dna) and to a lesser extent inhibits the formation of ribonucleic acid (rna).

Carcinogenesis and Mutagenesis and Impairment of Fertility:

Carcinogenesis, mutagenesis, impairment of fertility: adequate long-term studies in animals to evaluate carcinogenic potential have not been conducted with fluorouracil. in three in-vitro cell transformation assays, fluorouracil produced morphological transformation of cells. morphological transformation was also produced in one of these in-vitro assays by a metabolite of fluorouracil and the transformed cells produced malignant tumors when injected into immunosuppressed syngeneic mice. fluorouracil has been shown to exert mutagenic acitivity in the yeast cells, bacillus subtilis and drosophila assays. in addition, fluorouracil has produced chromosome damage at concentrations of 1.0 and 2.0 mcg/ml in an in vitro hamster fibroblast assay and increases in micronuclei formation in the bone marrow of mice at intraperitoneal doses within the human therapeutic dose range of 12-15 mg/kg/day. patients receiving cumulative doses of 0.24-1.0 g of fluorouracil parenterally have shown an increase Read more...

in numerical and structural chromosome aberrations in peripheral blood lymphocytes. fluorouracil has been shown to impair fertility after parenteral administration in rats. in mice, single-dose intravenous and intraperitoneal injections of fluorouracil have been reported to kill differentiated spermatogonia and spermatocytes at a dose of 500 mg/kg and produce abnormalities in spermatids at 50 mg/kg. fluorouracil was negative in the dominant lethal mutation assay performed in mice.

How Supplied:

How supplied fluoroplex (fluorouracil) 1% topical cream is available in 30 g tubes (ndc 16110-812-30) note: avoid freezing. store at 15Â° - 30Â°c (59Â° - 86Â°f) in tight containers. rx only

Information for Patients:

Information for patients: the medication should be applied with care near the eyes, nose, and mouth. excessive reaction in these areas may occur due to irritation from accumulation of drug. fluoroplex cream is applied with the fingers, and the hands should be washed immediately afterward. the reaction to fluoroplex cream in treated areas may be unsightly during therapy, and, in some cases, for several weeks following cessation of therapy. fluorouracil, including fluoroplex cream may be fatal if ingested by pets. avoid allowing pets to contact the fluoroplex cream container or the skin where fluoroplex Â® cream has been applied. store fluoroplex cream out of reach of pets. safely discard or clean any cloth or applicator that may retain fluoroplex cream and avoid leaving any residues of fluoroplex cream on your hands, clothing, carpeting or furniture.

Spl Patient Package Insert:

This patient information has been approved by the u.s. food and drug administration issued: february 2022 patient information fluoroplex Â® (floor-oh-plex) (fluorouracil) 1% topical cream important: fluoroplex cream is for use on skin only (topical). apply with care near the eyes, nose and mouth. what is fluoroplex cream? fluoroplex cream is a prescription medicine used on the skin to treat multiple actinic (solar) keratosis. it is not known if fluoroplex cream is safe and effective in children. who should not use fluoroplex cream? do not use fluoroplex cream if: you are pregnant or may become pregnant. fluoroplex cream may harm your unborn baby. stop using fluoroplex cream and tell your healthcare provider right away if you become pregnant while using fluoroplex cream. you are allergic to any of the ingredients in fluoroplex cream. see the end of this leaflet for a list of ingredients in fluoroplex cream. before using fluoroplex cream, tell your healthcare provider about all of your Read more...

medical conditions, including if you: are breastfeeding or plan to breastfeed. it is not known if fluoroplex cream passes into your breast milk. you should not breastfeed during treatment with fluoroplex cream. how should i use fluoroplex Â® topical cream? use fluoroplex cream exactly as your healthcare provider tells you. your healthcare provider will tell you where to apply fluoroplex cream, how often and how long to apply it. fluoroplex cream is usually applied 2 times a day for 2 to 6 weeks. use your fingertips to apply enough fluoroplex cream to cover the areas to be treated on your face or other affected areas, as instructed by your healthcare provider. skin reactions are expected when you use fluoroplex cream. these skin reactions begin with redness, usually followed by dryness or tenderness and crusting of your skin. before you see any healing of your skin, these skin reactions continue to progress. stop using fluoroplex cream when you see raw areas (erosion and ulcers) and shedding of dead skin (sloughing). be sure to follow your healthcare providerâs instructions about when to stop using fluoroplex cream. if your skin reaction bothers you or is severe, or if you are not sure what to do, call your healthcare provider for instructions. avoid letting fluoroplex cream build up in the skin folds around your eyes, nose or mouth. wash your hands right away after you apply fluoroplex cream. if you accidentally get fluoroplex cream in your eyes, flush your eyes with water or normal saline. what should i avoid while using fluoroplex cream? avoid covering the treated areas with an airtight dressing, unless your healthcare provider tells you to. avoid sunlight and ultraviolet lights, such as sun lamps and tanning machines. fluoroplex cream can make your skin sensitive to light. you could get a severe sunburn. do not breast feed or become pregnant while using fluoroplex cream. if you do become pregnant, stop using fluoroplex cream and tell your doctor right away. fluoroplex cream may be fatal to your pet if your pet licks or ingests fluoroplex cream. avoid allowing pets to contact the fluoroplex cream container or your skin where you applied fluoroplex cream. store fluoroplex cream out of reach of pets. safely discard or clean any cloth or applicator that may have fluoroplex cream residue avoid applying fluoroplex cream on your clothing, carpeting, or furniture. if your pet starts vomiting or starts having a seizure after your pet licks or ingests fluoroplex cream, seek immediate veterinary care for your pet. what are the possible side effects of fluoroplex cream? skin reactions including possible allergic reactions (allergic contact dermatitis). you may get skin reactions such as: pain itching burning irritation redness and swelling small blood vessels that can be seen under the skin darkening of the skin scarring tell your healthcare provider if you have any side effect that bothers you or that does not go away. these are not all the possible side effects of fluoroplex cream. for more information, ask your healthcare provider or pharmacist. call your doctor for medical advice about side effects. you may report side effects to fda at 1-800-fda-1088. how should i store fluoroplex cream? do not freeze fluoroplex cream. store fluoroplex cream between 59Â°f to 86Â°f (15Â°c to 30Â°c) in tight containers. keep fluoroplex cream and all medicines out of the reach of children. general information about the safe and effective use of fluoroplex cream. medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. do not use fluoroplex cream for a condition for which it was not prescribed. do not give fluoroplex cream to other people, even if they have the same symptoms you have. it may harm them. you can ask your pharmacist or healthcare provider for information about fluoroplex cream that is written for the health professionals. what are the ingredients in fluoroplex cream? active ingredient: fluorouracil inactive ingredients: benzyl alcohol, emulsifying wax, isopropyl myristate, mineral oil, purified water, and sodium hydroxide. Â® marks owned by almirall, llc manufactured by: almirall, llc, exton, pa 19341 u.s.a. made in germany for more information, call 1-866-665-2782.

Package Label Principal Display Panel:

Principal display panel - 30 g tube label ndc 16110-812-30 30 grams fluoroplex Â® (fluorouracil) 1% topical cream rx only contains: active: fluorouracil 1.0% inactives: benzyl alcohol; emulsifying wax; mineral oil; isopropyl myristate; sodium hydroxide; and purified water. dosage: refer to accompanying literature for complete prescribing information. avoid freezing. store at 15Â° - 30Â°c (59Â° - 86Â°f). see crimp for lot no. and expiration date manufactured by: almirall hermal gmbh, 21465 reinbek, germany distributed by: almirall, llc, exton, pa 19341, u.s.a. fluoroplex is a registered trademark of almirall, llc almirall, llc 30 g tube label

Principal display panel - 30 g carton label ndc 16110-812-30 30 grams fluoroplex Â® (fluorouracil) 1% topical cream contains: active: fluorouracil 1.0% inactives: benzyl alcohol; emulsifying wax; mineral oil; isopropyl myristate; sodium hydroxide; and purified water. rx only dosage: refer to accompanying literature for complete prescribing information. avoid freezing. store at 15Â° - 30Â°c (59Â° - 86Â°f). manufactured by: almirall hermal gmbh, 21465 reinbek, germany distributed by: almirall, llc, exton, pa 19341, u.s.a. fluoroplex is a registered trademark of almirall, llc almirall, llc 30 g carton label

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