Mometasone Furoate 1 mg/mL
Mometasone Furoate · SOLUTION · Bryant Ranch Prepack
Mometasone furoate is a prescription topical solution applied directly to the skin to reduce inflammation and itching caused by various skin conditions. This medication is a corticosteroid that works by suppressing immune responses in the affected area.
Key Facts
- Brand Name
- Mometasone Furoate
- Generic Name
- Mometasone Furoate
- NDC Code (Product)
72162-1392- Manufacturer
- Bryant Ranch Prepack
- Strength
- 1 mg/mL
- Dosage Form
- SOLUTION
- Route
- TOPICAL
- Marketing Status
- Application #
- ANDA077180
- Marketing Start
- 12/11/2008
Recall History
Cosette Pharmaceuticals, Inc.
CGMP Deviaitons
Perrigo Israel Pharmaceuticals
Subpotent drug
Intersect ENT, Inc.
Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: Market complaints related to "gritty texture".
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Organon Llc
Defective Container
CARDINAL HEALTHCARE
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Glenmark Pharmaceuticals Inc., USA
GMP Deviations: Glenmark received complaints stating that mometasone fuorate cream was gritty.
Glenmark Pharmaceuticals Inc., USA
Defective Container
ACP Nimble Buyer, Inc.
Labeling: Not Elsewhere Classified. Mometasone Furoate Cream has an NDC typographical error.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Mometasone furoate cream, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older. Mometasone furoate cream, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients ≥ 2 years of age. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Apply a thin film of mometasone furoate cream, 0.1% to the affected skin areas once daily. Mometasone furoate cream, 0.1% may be used in pediatric patients 2 years of age or older. Since safety and efficacy of mometasone furoate cream, 0.1% have not been established in pediatric patients below 2 years of age; use in this age group is not recommended [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.4 )]. Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary [see Warnings and Precautions (5.1)]. Do not use mometasone furoate cream, 0.1% with occlusive dressings unless directed by a physician. Do not apply mometasone furoate cream, 0.1% in the diaper area if the patient still requires diapers or plastic pants, as these garments may constitute occlusive dressing. Avoid contact with eyes. Wash hands after each application. Avoid use on the face, groin, or axillae. Mometasone furoate cream, 0.1% is for topical use only. It is not for oral, ophthalmic, or intravaginal use. • Apply a thin film to the affected skin areas once daily. ( 2 ) • Discontinue…
Contraindications
4 CONTRAINDICATIONS Mometasone furoate cream, 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation. Mometasone furoate cream, 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS No drug-drug interaction studies have been conducted with mometasone furoate cream.
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions are: burning, pruritus, and skin atrophy. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888)721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In controlled clinical trials involving 319 subjects, the incidence of adverse reactions associated with the use of mometasone furoate cream was 1.6%. Reported reactions included burning, pruritus, and skin atrophy. Reports of rosacea associated with the use of mometasone furoate cream have also been received. In controlled clinical trials (n=74) involving pediatric subjects 2 to 12 years of age, the incidence of adverse experiences associated with the use of mometasone furoate cream was approximately 7%. Reported reactions included stinging, pruritus, and furunculosis. The following adverse reactions were reported to be possibly or probab…
Frequently Asked Questions
What is Mometasone Furoate used for?
Mometasone furoate is a prescription topical solution applied directly to the skin to reduce inflammation and itching caused by various skin conditions. This medication is a corticosteroid that works by suppressing immune responses in the affected area.
Is Mometasone Furoate a controlled substance?
Mometasone Furoate is not classified as a controlled substance by the DEA.
What is the generic name for Mometasone Furoate?
The generic name for Mometasone Furoate is Mometasone Furoate. There are 6 other brand versions of Mometasone Furoate.
What is the NDC code for Mometasone Furoate 1 mg/mL?
The NDC (National Drug Code) for Mometasone Furoate 1 mg/mL is 72162-1392, listed by Bryant Ranch Prepack.