A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Aclovate Indications, Dosage, Storage, Stability - Alclometasone Dipropionate
Aclovate Indications, Dosage, Storage, Stability - Alclometasone Dipropionate
INDICATIONS
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.
DOSAGE AND ADMINISTRATION
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.
HOW SUPPLIED
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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