ELOCON Cream, 0.1%, is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid- responsive dermatoses.

ELOCON (mometasone furoate cream) Cream, 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 Section). Since safety and efficacy of ELOCON Cream 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 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 adequately established in pediatric patients below 2 years of age, its use in this age group is not recommended (see PRECAUTIONS - Pediatric Use Section).

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 Cream in pediatric patients for more than 3 weeks of use have not been established.

ELOCON Cream should not be used with occlusive dressings unless directed by a physician. ELOCON Cream 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 Cream 0.1%, is supplied in 15-g (NDC 0085-0567-01) and 45-g (NDC 0085-0567-02) tubes; boxes of one.

Store ELOCON Cream between 2° C and 25° C (36° F and 77° F).

ELOCON® brand of mometasone furoate cream, Cream 0.1%. For Dermatologic Use Only. Not for Ophthalmic Use. SP Schering Corporation, Kenilworth, NJ 07033 USA. Rev. 7/17/02. FDA Rev date: 7/17/2002

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