Quinixil Mometasone Furoate and Dimethicone Mometasone Furoate Mometasone Furoate Mometasone Furoate MOMETASONE Hexylene Glycol Phosphoric Acid Propylene Glycol Stearate Stearyl Alcohol Titanium Dioxide White Wax Petrolatum WATER Polyoxyl 20 Cetostearyl Ether Aluminum Starch Octenylsuccinate off-white Secura Dimethicone Protectant Dimethicone DIMETHICONE DIMETHICONE EDETATE DISODIUM ISOPROPYL PALMITATE METHYLPARABEN PARAFFIN PETROLATUM PROPYLENE GLYCOL PROPYLPARABEN SODIUM CHLORIDE WATER YELLOW WAX

Mometasone furoate cream 0.1% contains mometasone furoate for topical use. Mometasone furoate is a synthetic corticosteroid with anti-inflammatory activity. Chemically, mometasone furoate is 9α,21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2- furoate), with the empirical formula C 27 H 30 Cl 2 O 6 , a molecular weight of 521.4 and the following structural formula: Mometasone furoate is a white to off-white powder practically insoluble in water, slightly soluble in octanol, and moderately soluble in ethyl alcohol. Each gram of mometasone furoate cream 0.1% contains 1 mg mometasone furoate, USP in a cream base of hexylene glycol, phosphoric acid, propylene glycol stearate, stearyl alcohol and ceteareth-20, titanium dioxide, aluminum starch octenylsuccinate, white wax, white petrolatum, and purified water. Structural Formula

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) 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

Brief instructions: Apply a thin film to the affected skin areas once daily. (2) Discontinue therapy when control is achieved. (2) If no improvement is seen within 2 weeks, reassess diagnosis. (2) Do not use with occlusive dressings unless directed by a physician. (2) Detailed description: 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. Directions Apply as needed Change wet and soiled diapers, garments, and linens promptly Cleanse the affected area and allow to dry Apply cream liberally as often as necessary with each diaper, garment or linen change; especially at bedtime or anytime when exposure to soiled diapers, garments, linens, feces, or urine may be prolonged

Mometasone furoate cream 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.

Most common adverse reactions are: burning, pruritus, and skin atrophy. (6) To report SUSPECTED ADVERSE REACTIONS, contact G&W Laboratories, Inc. at 1-800-922-1038 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 0.1% was 1.6%. Reported reactions included burning, pruritus, and skin atrophy. Reports of rosacea associated with the use of mometasone furoate cream 0.1% 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 0.1% was approximately 7%. Reported reactions included stinging, pruritus, and furunculosis. The following adverse reactions were reported to be possibly or probably related to treatment with mometasone furoate cream 0.1% during clinical trials in 4% of 182 pediatric subjects 6 months to 2 years of age: decreased glucocorticoid levels, 2; paresthesia, 2; folliculitis, 1; moniliasis, 1; bacterial infection; 1 skin depigmentation, 1. The following signs of skin atrophy were also observed among 97 subjects treated with mometasone furoate cream 0.1% in a clinical trial: shininess, 4; telangiectasia, 1; loss of elasticity, 4; loss of normal skin markings, 4; thinness, 1; and bruising, 1. 6.2 Postmarketing Experience Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Postmarketing reports for local adverse reactions to topical corticosteroids include irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae, and miliaria. These adverse reactions may occur more frequently with the use of occlusive dressings. Postmarketing reports for ophthalmic adverse reactions to topical corticosteroids include blurred vision, cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy. To report SUSPECTED ADVERSE REACTIONS, contact G&W Laboratories, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

No drug-drug interaction studies have been conducted with mometasone furoate cream 0.1%.

Purpose Skin Protectant

Do not use on deep or puncture wounds animal bites serious burns

When using this product do not get into eyes

Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

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