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These highlights do not include all the information needed to use MOMETASONE FUROATE CREAM safely and effectively. See full prescribing information for MOMETASONE FUROATE CREAM. MOMETASONE FUROATE Cream, 0.1% for topical use Initial U.S. Approval: 1987 | Mometasone Furoate [Glenmark Pharmaceuticals Inc., USA] | BioPortfolio

13:34 EST 27th January 2019 | BioPortfolio

Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

Manufactured by:

Glenmark Pharmaceuticals Ltd. Village Kishanpura, Baddi Nalagarh RoadDistrict : Solan, Himachal Pradesh - 173205, India

Manufactured for:

Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430

Questions? 1 (888)721-7115www.glenmarkpharma.com/usa

June 2018

Mometasone Furoate (moe-MET-a-sone-FYOOR-oh-ate)

Cream, 0.1%

Important information: Mometasone furoate cream is for use on skin only. Do not use mometasone furoate cream in your eyes, mouth, or vagina.

What is Mometasone furoate cream?

Do not use mometasone furoate cream if you are allergic to mometasone furoate or any of the ingredients in mometasone furoate cream, 0.1%. See the end of this leaflet for a complete list of ingredients in mometasone furoate cream.

Before using mometasone furoate cream, tell your healthcare provider about all your medical conditions, including if you:

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your healthcare provider if you take other corticosteroid medicines by mouth or use other products on your skin or scalp that contain corticosteroids.

How should I use mometasone furoate cream?

What are the possible side effects of mometasone furoate cream?

Mometasone furoate cream may cause serious side effects, including:

The most common side effects of mometasone furoate cream include burning, itching, and thinning of the skin (atrophy). These are not all the possible side effects of mometasone furoate cream.

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 mometasone furoate cream?

General information about the safe and effective use of mometasone furoate cream.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use mometasone furoate cream for a condition for which it was not prescribed. Do not give mometasone furoate cream to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about mometasone furoate cream that is written for health professionals.

What are the ingredients in mometasone furoate cream, 0.1%?

Active ingredient: mometasone furoate

Inactive ingredients: aluminum starch octenyl succinate (Dry-Flo Pure), hexylene glycol, phosphoric acid, propylene glycol monostearate, purified water, stearyl alcohol and ceteareth-20, titanium dioxide, white petrolatum, and white wax.

Manufactured by:

Glenmark Pharmaceuticals Ltd.

Village Kishanpura, Baddi Nalagarh Road

District : Solan, Himachal Pradesh - 173205, India

Manufactured for:

Glenmark Pharmaceuticals Inc., USA

Mahwah, NJ 07430

Questions? 1 (888)721-7115

www.glenmarkpharma.com/usa

June 2018

This Patient Information has been approved by the U.S. Food and Drug Administration.

NDC 68462-192-55Mometasone Furaoate Cream USP, 0.1%For dermatologic use only. Not for ophthalmic use.

Manufacturer

Glenmark Pharmaceuticals Inc., USA

Active Ingredients

Source

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NA

Mometasone furoate [physicians total care, inc.]

Mometasone Furoate Cream USP 0.1%

Clinical Trials [142 Associated Clinical Trials listed on BioPortfolio]

A Study of Mometasone Furoate Nasal Spray in Perennial Allergic Rhinitis (Study P03748)(COMPLETED)

This is a multicenter, randomized, double-blind within the dose level, parallel group comparison of mometasone furoate nasal spray in subjects with perennial allergic rhinitis to examine t...

A Serious Asthma Outcome Study With Mometasone Furoate/Formoterol Versus Mometasone Furoate in Asthmatics 12 Years and Over (P06241 AM3)

The purpose of this study is to test the safety of DULERA. DULERA is a pressurized metered-dose inhaler (MDI) that contains two drugs combined, namely mometasone and formoterol in a single...

A Study of Mometasone Furoate Metered Dose Inhaler in Children With Persistent Asthma (P04223)

The primary objective of this study is to demonstrate the dose-related efficacy, by evaluating morning (AM) lung function at the end of the dosing interval (AM pre-dose percent predicted f...

Randomized Study to Compare the Bioavailability of Three Mometasone Furoate 0.1% Topical Lotions

The purpose of this study was to compare the relative vasoconstrictive effects of two test and one reference Mometasone Furoate 0.1% Topical Lotions in healthy, female subjects.

Mometasone Furoate and Oxymetazoline in the Treatment of Adenoid Hypertrophy

The purpose of this study is to determine the effect of MF/OXY in the treatment of adenoid hypertrophy children with severe allergic rhinitis.

PubMed Articles [7 Associated PubMed Articles listed on BioPortfolio]

Serious Asthma Events with Mometasone Furoate Plus Formoterol Compared With Mometasone Furoate.

The safety of long-acting beta agonists added to inhaled corticosteroids for the treatment of persistent asthma has been controversial.

Effects of mometasone furoate-impregnated biodegradable nasal dressing on endoscopic appearance in healing process following endoscopic sinus surgery: a randomized, double-blind, placebo-controlled study.

Postoperative care is an important factor affecting the outcome of endoscopic sinus surgery (ESS) in patients with chronic rhinosinusitis (CRS). The aim of this study was to test the effect of mometas...

Indacaterol acetate/mometasone furoate provides sustained improvements in lung function compared with salmeterol xinafoate/fluticasone propionate in patients with moderate-to-very-severe COPD: results from a Phase II randomized, double-blind 12-week study.

Fixed-dose combinations of a long-acting beta agonist and an inhaled corticosteroid are more effective than the individual components in COPD. The primary study objective was to demonstrate that the c...

Olopatadine/Mometasone Combination Nasal Spray Improves Seasonal Allergic Rhinitis Symptoms in an Environmental Exposure Chamber Study.

GSP301 nasal spray is a fixed-dose combination of the antihistamine olopatadine hydrochloride and the corticosteroid mometasone furoate intended for seasonal allergic rhinitis (SAR) treatment.

A mometasone-eluting sinus implant (Sinuva) for nasal polyps.

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