ELOCON Ointment, 0.1%, is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ELOCON (mometasone furoate ointment) Ointment, 0.1%, may be used in pediatric patients 2 years of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established (see PRECAUTIONS - Pediatric Use). Since safety and efficacy of ELOCON Ointment have not been adequately established in pediatric patients below 2 years of age, its use in this age group is not recommended.

Apply a thin film of ELOCON Ointment to the affected skin areas once daily. ELOCON Ointment may be used in pediatric patients 2 years of age or older. Since safety and efficacy of ELOCON Ointment have not been adequately established in pediatric patients below 2 years of age, its use in this age group is not recommended. (see PRECAUTIONS - Pediatric Use).

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

Safety and efficacy of ELOCON Ointment in pediatric patients for more than 3 weeks have not been established.

ELOCON Ointment should not be used with occlusive dressings unless directed by a physician. ELOCON Ointment should not be applied in the diaper area if the child still requires diapers or plastic pants as these garments may constitute occlusive dressing.

ELOCON Ointment, 0.1%, is supplied in 15-g (NDC 0085-0370-01) and 45-g (NDC 0085-0370-02) tubes; boxes of one.

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

ELOCON® brand of mometasone furoate ointment, Ointment 0.1%, For Dermatologic Use Only. Not for Ophthalmic Use. SP Schering Corporation, Kenilworth, NJ 07033 USA. Rev. 9/18/02. FDA Rev date: 12/15/2002

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