Mometasone Lotion

Name: Mometasone Lotion

Mometasone Lotion Dosage and Administration

Apply a few drops of Mometasone Furoate Topical Solution USP, 0.1% to the affected skin areas once daily and massage lightly until it disappears.

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) and Use in Specific Populations (8.4)].

Mometasone Furoate Topical Solution USP, 0.1% should not be used with occlusive dressings unless directed by a physician. Mometasone Furoate Topical Solution USP, 0.1% should not be applied in the diaper area if the patient still requires diapers or plastic pants, as these garments may constitute occlusive dressing.

Mometasone Furoate Topical Solution USP, 0.1% is for topical use only. It is not for oral, ophthalmic, or intravaginal use. Avoid use on the face, groin, or axillae.

Dosage Forms and Strengths

Solution, 0.1%. Each gram of Mometasone Furoate Topical Solution USP, 0.1% contains 1 mg of mometasone furoate in a colorless, clear to translucent solution base.

Contraindications

None.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential of mometasone furoate lotion. Long-term carcinogenicity studies of mometasone furoate were conducted by the inhalation route in rats and mice. In a 2-year carcinogenicity study in Sprague Dawley rats, mometasone furoate demonstrated no statistically significant increase of tumors at inhalation doses up to 67 mcg/kg (approximately 0.04 times the estimated maximum clinical topical dose from mometasone furoate lotion on a mcg/m2 basis). In a 19-month carcinogenicity study in Swiss CD-1 mice, mometasone furoate demonstrated no statistically significant increase in the incidence of tumors at inhalation doses up to 160 mcg/kg (approximately 0.05 times the estimated maximum clinical topical dose from mometasone furoate lotion on a mcg/m2 basis).

Mometasone furoate increased chromosomal aberrations in an in vitro Chinese hamster ovary cell assay, but did not increase chromosomal aberrations in an in vitro Chinese hamster lung cell assay. Mometasone furoate was not mutagenic in the Ames test or mouse lymphoma assay, and was not clastogenic in an in vivo mouse micronucleus assay, a rat bone marrow chromosomal aberration assay, or a mouse male germ-cell chromosomal aberration assay. Mometasone furoate also did not induce unscheduled DNA synthesis in vivo in rat hepatocytes.

In reproductive studies in rats, impairment of fertility was not produced in male or female rats by subcutaneous doses up to 15 mcg/kg (approximately 0.01 times the estimated maximum clinical topical dose from mometasone furoate lotion on a mcg/m2 basis).

How Supplied/Storage and Handling

Mometasone Furoate Topical Solution USP, 0.1% is colorless, clear to translucent and supplied in 30-mL (27.5 gram) (NDC 45802-118-59) and 60-mL (55 gram) (NDC 45802-118-46) bottles; boxes of one.

Store Mometasone Furoate Topical Solution USP, 0.1% at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Principal Display Panel - Carton

Rx Only

NDC 45802-118-46

Mometasone Furoate Topical Solution USP, 0.1%

For Dermatologic Use Only.

Not for Ophthalmic Use.

60 mL (55 g)

MOMETASONE FUROATE 
mometasone furoate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:45802-118
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MOMETASONE FUROATE (MOMETASONE) MOMETASONE FUROATE 1 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
ISOPROPYL ALCOHOL  
HEXYLENE GLYCOL  
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS  
WATER  
GLYCERIN  
OLEIC ACID  
PHOSPHORIC ACID  
Packaging
# Item Code Package Description
1 NDC:45802-118-59 1 BOTTLE in 1 CARTON
1 30 mL in 1 BOTTLE
2 NDC:45802-118-46 1 BOTTLE in 1 CARTON
2 60 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077180 12/11/2008
Labeler - Perrigo New York Inc (078846912)
Revised: 05/2017   Perrigo New York Inc
(web3)