ACLOVATE Cream and Ointment are low to medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ACLOVATE Cream and Ointment may be used in pediatric patients 1 year 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 the safety and efficacy of ACLOVATE Cream and Ointment have not been established in pediatric patients below 1 year of age, their use in this age-group is not recommended.

Apply a thin film of ACLOVATE Cream or Ointment to the affected skin areas two or three times daily; massage gently until the medication disappears.

ACLOVATE Cream and Ointment may be used in pediatric patients 1 year of age or older. Safety and effectiveness of ACLOVATE Cream or Ointment in pediatric patients for more than 3 weeks of use have not been established. Use in pediatric patients under 1 year of age is not recommended.

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. ACLOVATE Cream or Ointment should not be used with occlusive dressings unless directed by a physician. ACLOVATE Cream or 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.

Geriatric Use: In studies where geriatric patients (65 years of age or older, see PRECAUTIONS) have been treated with ACLOVATE Cream or Ointment, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

ACLOVATE Cream, 0.05% is supplied in

15-g (NDC 0173-0401-00),
45-g (NDC 0173-0401-01), and
60-g (NDC 0173-0401-06) tubes.

ACLOVATE Ointment, 0.05% is supplied in

15-g (NDC 0173-0402-00),
45-g (NDC 0173-0402-01), and
60-g (NDC 0173-0402-06) tubes.

Storage: Store between 2° and 30° C (36° and 86° F).

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