Quinixil (Page 3 of 4)

14 CLINICAL STUDIES

The safety and efficacy of the mometasone furoate cream 0.1% for the treatment of corticosteroid-responsive dermatoses were evaluated in two randomized, double-blind, vehicle-controlled clinical trials, one in psoriasis and one in atopic dermatitis. A total 366 subjects (12-81 years of age), of whom 177 received mometasone furoate cream 0.1% and 181 subjects received vehicle cream, were evaluated in these trials. Mometasone furoate cream 0.1% or the vehicle cream were applied once daily for 21 days.

The two trials showed mometasone furoate cream 0.1% is effective in the treatment of psoriasis and atopic dermatitis.

16 HOW SUPPLIED/STORAGE AND HANDLING

Mometasone furoate cream 0.1% is supplied in 15 g (0713-0634-15) and 45 g (NDC 0713-0634-37) tubes; boxes of one.

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Avoid excessive heat.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information). Inform patients of the following:
• Use mometasone furoate cream 0.1% as directed by the physician. It is for external use only.
• Avoid contact with the eyes.
• Advise patients to report any visual symptoms to their healthcare providers.
• Do not use mometasone furoate cream 0.1% on the face, underarms, or groin areas unless directed by the physician.
• Do not use mometasone furoate cream 0.1% for any disorder other than that for which it was prescribed.
• Do not bandage or otherwise cover or wrap the treated skin area so as to be occlusive, unless directed by the physician.
• Report any signs of local adverse reactions to the physician.
• Advise patients not to use mometasone furoate cream 0.1% in the treatment of diaper dermatitis. Do not apply mometasone furoate cream 0.1% in the diaper area, as diapers or plastic pants may constitute occlusive dressing.
• Discontinue therapy when control is achieved. If no improvement is seen within 2 weeks, contact the physician.
• Do not use other corticosteroid-containing products with mometasone furoate cream 0.1% without first consulting with the physician.

Patient Information

Mometasone Furoate Cream 0.1%
(Mo-meta-sone fur-o-ate)

Important information: Mometasone Furoate Cream 0.1% is for use on skin only. Do not use mometasone furoate cream 0.1% in your eyes, mouth, or vagina.

What is mometasone furoate cream 0.1%?
• Mometasone furoate cream 0.1% is a prescription medicine used on the skin (topical) for the relief of redness, swelling, heat, pain (inflammation) and itching, caused by certain skin problems in people 2 years of age and older.
• It is not known if mometasone furoate cream 0.1% is safe and effective for use in children under 2 years of age.
• Mometasone furoate cream 0.1% should not be used in children under 2 years of age.
• It is not known if mometasone furoate cream 0.1% is safe and effective for use in children longer than 3 weeks.

Do not use mometasone furoate cream 0.1% 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 0.1%.

Before using mometasone furoate cream 0.1%, tell your healthcare provider about all your medical conditions, including if you:
• have a skin infection at the site to be treated. You may also need medicine to treat the skin infection.
• are pregnant or plan to become pregnant. It is not known if mometasone furoate cream 0.1% will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if mometasone furoate cream 0.1% passes into your breast milk.

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 0.1%?
• Use mometasone furoate cream 0.1% exactly as your healthcare provider tells you to use it.
• Apply a thin film of mometasone furoate cream 0.1% to the affected skin area 1 time each day.
• Tell your healthcare provider if the treated skin area does not get better after 2 weeks of treatment.
• Do not bandage, cover, or wrap the treated skin area unless your healthcare provider tells you to.
• Mometasone furoate cream 0.1% should not be used to treat diaper rash or redness. Do not apply mometasone furoate cream 0.1% in the diaper area if wearing diapers or plastic pants.
• Avoid using mometasone furoate cream 0.1% on the face, groin, or underarms (armpits).
• Wash your hands after applying mometasone furoate cream 0.1%.

What are the possible side effects of mometasone furoate cream 0.1%?
Mometasone furoate cream 0.1% may cause serious side effects, including:
• Mometasone furoate cream 0.1% can pass through your skin. Too much mometasone furoate cream 0.1% passing through your skin can cause your adrenal glands to stop working properly. Your healthcare provider may do blood tests to check for adrenal gland problems.
• Vision problems. Topical corticosteroids may increase your chance of developing vision problems such as cataract and glaucoma. Tell your healthcare provider if you develop blurred vision or other vision problems during treatment with mometasone furoate cream 0.1%.
• Skin problems. Skin problems may happen during treatment with mometasone furoate cream 0.1%, including allergic reactions (contact dermatitis) and skin infections at the treatment site. Stop using mometasone furoate cream 0.1% and tell your healthcare provider if you develop any skin reactions such as pain, tenderness, swelling, or problems healing during treatment with mometasone furoate cream 0.1%.

The most common side effects of mometasone furoate cream 0.1% include burning, itching, and thinning of the skin (atrophy).
These are not all the possible side effects of mometasone furoate cream 0.1%.
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 0.1%?
• Store mometasone furoate cream 0.1% at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Avoid excessive heat.
• Keep mometasone furoate cream 0.1% and all medicines out of the reach of children.

General information about the safe and effective use of mometasone furoate cream 0.1%.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use mometasone furoate cream 0.1% for a condition for which it was not prescribed. Do not give mometasone furoate cream 0.1% 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 0.1% that is written for health professionals.

What are the ingredients in mometasone furoate cream 0.1%?
Active ingredient: mometasone furoate
Inactive ingredients: hexylene glycol, phosphoric acid, propylene glycol stearate, stearyl alcohol and ceteareth-20, titanium dioxide, aluminum starch ocetnylsuccinate, white wax, white petrolatum, and purified water.

Manufactured by:
G&W Laboratories, Inc.
111 Coolidge Street
South Plainfield, NJ 07080

8-0634GW4
Rev. 06/2018

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

Mometasone Furoate packaging

NDC 0713-0634-1515 g carton (Note: the 45 g carton is the product actually included in this kit)

Mometasone Furoate packaging
(click image for full-size original)

DIMETHICONE Drug Facts

Active ingredient

Dimethicone 5.0%

Purpose

Skin Protectant

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

  • Helps treat and prevent diaper dermatitis
  • Protects minor skin irritation associated with diaper dermatitis and helps protect from wetness
  • Temporarily protects and helps relieve chapped or cracked skin and lips

Warnings

For external use only

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