Drug Catalog - Product Detail
MIRVASO GEL 0.33% 30GM TOPICAL APPLICATION
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00299-5980-30 | GALDERMA | 30 | 0.33% | GEL |
PACKAGE FILES
Generic Name
BRIMONIDINE TARTRATE
Substance Name
BRIMONIDINE TARTRATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
NDA204708
Description
11 DESCRIPTION MIRVASO (brimonidine) topical gel, 0.33% contains brimonidine tartrate, an alpha adrenergic agonist. The molecular formula of brimonidine tartrate is C 11 H 10 BrN 5 • C 4 H 6 O 6 . It has the following structural formula: Chemically, brimonidine tartrate is 5-Bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate. Brimonidine tartrate has a molecular weight of 442.24 and appears as white to slightly yellowish powder. Each gram of MIRVASO (brimonidine) topical gel, 0.33% contains 5 mg of the active ingredient brimonidine tartrate (equivalent to 3.3 mg of brimonidine free base), in a white to light yellow opaque gel composed of the inactive ingredients carbomer homopolymer type B, glycerin, methylparaben, phenoxyethanol, propylene glycol, purified water, sodium hydroxide, and titanium dioxide. chem-structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING MIRVASO (brimonidine) topical gel, 0.33% is a white to light yellow opaque gel, supplied in a laminated tube or pump with a child resistant cap in the following sizes: 30 gram tube NDC 0299-5980-30 30 gram pump NDC 0299-5980-35 45 gram tube NDC 0299-5980-45 Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [See USP Controlled Room Temperature].
Indications & Usage
1 INDICATIONS AND USAGE MIRVASO (brimonidine) topical gel, 0.33% is an alpha adrenergic agonist indicated for the topical treatment of persistent (nontransient) erythema of rosacea in adults 18 years of age or older. MIRVASO (brimonidine) topical gel, 0.33% is an alpha adrenergic agonist indicated for the topical treatment of persistent (nontransient) facial erythema of rosacea in adults 18 years of age or older.( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Apply a pea-sized amount once daily to each of the five areas of the face: central forehead, chin, nose, each cheek. MIRVASO topical gel should be applied smoothly and evenly as a thin layer across the entire face avoiding the eyes and lips. Wash hands after applying MIRVASO topical gel. MIRVASO topical gel is for topical use only and not for oral, ophthalmic, or intravaginal use. Apply a pea-sized amount once daily to each of the five areas of the face (forehead, chin, nose, each cheek) avoiding the eyes and lips. ( 2 ) Hands should be washed immediately after applying MIRVASO topical gel. ( 2 ) For topical use only ( 2 ) Not for oral, ophthalmic, or intravaginal use. ( 2 )