Desonide (Page 2 of 2)

Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing’s syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment.

Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.

HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

ADVERSE REACTIONS

In controlled clinical trials, the total incidence of adverse reactions associated with the use of Desonide Cream, 0.05% was approximately 1%. These adverse reactions were pruritus, pain, folliculitis, rash, peripheral edema, pustular rash, sweating, erythema, irritation, and burning. Laboratory abnormalities were found in 3% of the patients. These were hyperglycemia (2%) and liver function abnormality (1%).

The following additional local adverse reactions have been reported infrequently with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in approximate decreasing order of occurrence: dryness, folliculitis, acneiform eruptions, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, miliaria, burning and hypopigmentation.

OVERDOSAGE

Topically applied Desonide Cream, 0.05% can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

DOSAGE AND ADMINISTRATION

Desonide Cream, 0.05% should be applied to the affected area as a thin film two to four times daily depending on the severity of the condition.

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

Desonide Cream, 0.05% should not be used with occlusive dressings.

HOW SUPPLIED

Desonide Cream, 0.05% is available as follows:

15 g tube (NDC 42254-142-15)

STORAGE

Store at 20-25°C (68-77°F)[see USP Controlled Room Temperature].

MANUFACTURED BY

PERRIGO

BRONX, NY 10457

DISTRUBUTED BY

PERRIGO®

ALLEGAN, MI 49010

Rev. 08/09

1A700 RC J3

REPACKAGED BY:

REBEL DISTRIBUTORS CORP

THOUSAND OAKS, CA 91320

Principal Display Panel

Desonide 0.05%
(click image for full-size original)

DESONIDE
desonide cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42254-142(NDC:45802-422)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DESONIDE (DESONIDE) DESONIDE 0.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ALUMINUM SULFATE
CALCIUM ACETATE
CETOSTEARYL ALCOHOL
ICODEXTRIN
GLYCERIN
LIGHT MINERAL OIL
WATER
SODIUM LAURYL SULFATE
PETROLATUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42254-142-15 1 TUBE (TUBE) in 1 CARTON contains a TUBE
1 15 g in 1 TUBE This package is contained within the CARTON (42254-142-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017010 04/11/2006
Labeler — Rebel Distributors Corp (118802834)
Establishment
Name Address ID/FEI Operations
Rebel Distributors Corp 118802834 RELABEL, REPACK

Revised: 01/2012 Rebel Distributors Corp

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