Metrolotion
Metronidazole
Galderma Laboratories, L.p.
Human Prescription Drug
NDC 0299-3838Metrolotion also known as Metronidazole is a human prescription drug labeled by 'Galderma Laboratories, L.p.'. National Drug Code (NDC) number for Metrolotion is 0299-3838. This drug is available in dosage form of Lotion. The names of the active, medicinal ingredients in Metrolotion drug includes Metronidazole - 7.5 mg/mL . The currest status of Metrolotion drug is Active.
Drug Information:
| Drug NDC: | 0299-3838 |
| 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: | Metrolotion |
| 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: | Metronidazole |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Galderma Laboratories, L.p. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Lotion |
| 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: | METRONIDAZOLE - 7.5 mg/mL
|
| 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: | 24 Nov, 1998 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 25 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: | NDA020901 |
| 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: | Galderma Laboratories, L.P.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 242736
261119
|
| 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: | N0000175435
M0014907
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 140QMO216E
|
| 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 EPC: | Nitroimidazole Antimicrobial [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 CS: | Nitroimidazoles [CS]
|
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. |
| Pharmacologic Class: | Nitroimidazole Antimicrobial [EPC]
Nitroimidazoles [CS]
|
| 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 |
|---|
| 0299-3838-02 | 1 BOTTLE, PLASTIC in 1 CARTON (0299-3838-02) / 59 mL in 1 BOTTLE, PLASTIC | 24 Nov, 1998 | 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:
Metrolotion metronidazole metronidazole metronidazole benzyl alcohol carbomer homopolymer type a (allyl pentaerythritol crosslinked) cyclomethicone glycerin glyceryl monostearate light mineral oil peg-100 stearate polyethylene glycol 400 potassium sorbate water steareth-21 stearyl alcohol sodium hydroxide lactic acid, unspecified form metrolotion-carton-image
Indications and Usage:
Indications and usage metrolotion ® topical lotion is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.
Dosage and Administration:
Dosage and administration apply a thin layer to entire affected areas after washing. use morning and evening or as directed by physician. avoid application close to the eyes. patients may use cosmetics after waiting for the metrolotion ® topical lotion to dry (not less than 5 minutes).
Contraindications:
Contraindications metrolotion ® topical lotion is contraindicated in individuals with a history of hypersensitivity to metronidazole or to other ingredients of the formulation.
Adverse Reactions:
Adverse reactions in a controlled clinical trial, safety data from 141 patients who used metrolotion ® topical lotion (n=71), or the lotion vehicle (n=70), twice daily and experienced a local cutaneous adverse event which may or may not have been related to the treatments include: local allergic reaction, metrolotion ® topical lotion 2 (3%), lotion vehicle 0; contact dermatitis, metrolotion ® topical lotion 2 (3%), lotion vehicle 1 (1%); pruritus, metrolotion ® topical lotion 1 (1%), lotion vehicle 0; skin discomfort (burning and stinging), metrolotion ® topical lotion 1 (1%), lotion vehicle 2 (3%); erythema, metrolotion ® topical lotion 4 (6%), lotion vehicle 0; dry skin, metrolotion ® topical lotion 0, lotion vehicle 1 (l%); and worsening of rosacea, metrolotion ® topical lotion 1 (1%), lotion vehicle 7 (10%). the following additional adverse experiences have been reported with the topical use of metronidazole: skin irritation, transient redness, metallic tast
Read more...e, tingling or numbness of extremities, and nausea.
Description:
Description metrolotion ® (metronidazole lotion) topical lotion contains metronidazole, usp, at a concentration of 7.5 mg per gram (0.75% w/w) in a lotion consisting of benzyl alcohol, carbomer 941, cyclomethicone, glycerin, glyceryl stearate, light mineral oil, peg-100 stearate, polyethylene glycol 400, potassium sorbate, purified water, steareth-21, stearyl alcohol, and sodium hydroxide and/or lactic acid to adjust ph. metronidazole is an imidazole and is classified therapeutically as an antiprotozoal and antibacterial agent. chemically, metronidazole is 2-methyl-5-nitro-1 h -imidazole-1-ethanol. the molecular formula is c 6 h 9 n 3 o 3 and molecular weight is 171.16. metronidazole is represented by the following structural formula: p52497-0-chem-struct
Clinical Pharmacology:
Clinical pharmacology the mechanisms by which metronidazole acts in the treatment of rosacea are unknown, but appear to include an anti-inflammatory effect. pharmacokinetics: absorption of metronidazole after topical application of metrolotion ® topical lotion is less complete and more prolonged than after oral administration. detectable plasma levels were found in all subjects following the administration of a 1 gram dose of metrolotion ® topical lotion (containing 7.5 mg of metronidazole) applied every morning and evening for 4 days to the faces of 8 patients. the highest concentration (96 ng/ml) seen following the morning dose on day 5 was approximately 80 times lower than the peak concentrations produced by a single 250 mg tablet of metronidazole. the mean (± sd) auc 0-24 after twice daily administration was 962 ± 373 ng.hr/ml.
Clinical Studies:
Clinical studies a controlled clinical study was conducted in 144 patients with moderate to severe rosacea, in which metrolotion ® topical lotion was compared with its vehicle. applications were made twice daily for 12 weeks during which patients were instructed to avoid spicy foods, thermally hot foods and drinks, alcoholic beverages, and caffeine. patients were also provided samples of a soapless cleansing lotion and, if requested, a moisturizer. metrolotion ® topical lotion was significantly more effective than its vehicle in mean percent reduction of inflammatory lesions associated with rosacea and in the investigatorsâ global assessment of improvement. the results of the mean percent reduction in inflammatory lesion counts from baseline after 12 weeks of treatment and the investigatorsâ global assessment of improvement at week 12 are presented in the following table: efficacy outcomes at week 12 mean percent reduction in inflammatory lesion counts from baseline met
Read more...rolotion® topical lotion n=65 vehicle lotion n=60 55% 20% investigators' global assessment of improvement (percent change from baseline) worse no change minimal improvement definite improvement marked improvement clear metrolotion® topical lotion n=65 5% 12% 11% 32% 32% 8% vehicle lotion n=60 15% 27% 23% 15% 20% 0% the scale is based on the following definitions: worse: exacerbation of either erythema or quantitative assessment of papules and/or pustules. no change: condition remains the same. minimal improvement: slight improvement in the quantitative assessment of papules and/or pustules, and/or slight improvement in erythema. definite improvement: more pronounced improvement in the quantitative assessment of papules and/or pustules, and/or more pronounced improvement in erythema. marked improvement: obvious improvement in the quantitative assessment of papules and/or pustules, and/or obvious improvement in erythema. clear: no papules or pustules and minimal residual or no erythema.
How Supplied:
How supplied metrolotion ® (metronidazole lotion) topical lotion, 0.75% is supplied in the following size: 2 fl. oz. (59 ml) plastic bottle - ndc 0299-3838-02 storage: store at controlled room temperature 68° to 77°f (20° - 25°c). protect from freezing. marketed by: galderma laboratories, l.p. fort worth, texas 76177 usa made in canada all trademarks are the property of their respective owners. p53319-0 revised: february 2017
Package Label Principal Display Panel:
Package label rx only ndc 0299-3838-02 metrolotion ® (metronidazole lotion) topical lotion 0.75% 2 fl oz (59 ml) galderma for topical use only. not for ophthalmic use. usual dosage: apply a thin layer to entire affected areas after washing. use morning and evening or as directed by physician. avoid application close to the eyes. each gram contains: active: metronidazole, 0.75% w/w (7.5 mg). inactive: benzyl alcohol, carbomer 941, cyclomethicone, glycerin, glyceryl stearate, light mineral oil, peg-100 stearate, polyethylene glycol 400, potassium sorbate, purified water, steareth-21, stearyl alcohol, and sodium hydroxide and/or lactic acid to adjust ph. see lot number and expiration date on bottom of carton. store at controlled room temperature 68º to 77ºf (20º â 25ºc). protect from freezing. marketed by: galderma laboratories, l.p. fort worth, texas 76177 usa all trademarks are the property of their respective owners. p53320-0 made in canada