ELOCON Cream, 0.1% Ref.[10556] Active ingredients: Mometasone

Source: FDA, National Drug Code (US)  Revision Year: 2020 

1. Indications and Usage

ELOCON Cream 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.

2. Dosage and Administration

Apply a thin film of ELOCON Cream to the affected skin areas once daily. ELOCON Cream may be used in pediatric patients 2 years of age or older. Since safety and efficacy of ELOCON Cream 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 ELOCON Cream with occlusive dressings unless directed by a physician. Do not apply ELOCON Cream 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.

ELOCON Cream is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

10. Overdosage

Topically applied ELOCON Cream can be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions (5.1)].

16.2. Storage and Handling

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

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