Desonide - Desonide lotion prescribing information
INDICATIONS AND USAGE
Desonide lotion is a low to medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.
DOSAGE AND ADMINISTRATION
Desonide lotion should be applied to the affected areas as a thin film two or three times daily depending on the severity of the condition. SHAKE LOTION WELL BEFORE USING.
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.
Desonide lotion should not be used with occlusive dressings.
CONTRAINDICATIONS
Desonide lotion is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.
ADVERSE REACTIONS
In controlled clinical trials, the total incidence of adverse reactions associated with the use of desonide was approximately 8%. These were: stinging and burning approximately 3%, irritation, contact dermatitis, condition worsened, peeling of skin, itching, intense transient erythema, and dryness/scaliness, each less than 2%.
The following additional local adverse reactions have been reported infrequently with other topical corticosteroids, and they may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, secondary infection, skin atrophy, striae, and miliaria.
To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals, Inc. at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DESCRIPTION
Desonide Lotion USP, 0.05% contain desonide, USP (Pregna-1,4-diene-3,20-dione,11,21- dihydroxy-16,17 [(1-methylethylidene) bis (oxy)]- (11β,16α)- a synthetic nonfluorinated corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and anti-pruritic agents.
Chemically, desonide, USP is C 24 H 32 O 6 . It has the following structural formula:
Desonide, USP has the molecular weight of 416.51. It is a white to almost white crystalline powder which is practically insoluble in water, sparingly soluble in ethanol and in acetone, soluble in chloroform.
Each gram of desonide lotion USP, 0.05% contains 0.5 mg of desonide, USP in a base of cetyl alcohol, edetate disodium, glyceryl stearate SE, light mineral oil, methylparaben, propylene glycol, propylparaben, purified water, sodium lauryl sulfate, sorbitan monostearate, and stearyl alcohol. May contain citric acid and/or sodium hydroxide for pH adjustment.
CLINICAL PHARMACOLOGY
Like other topical corticosteroids, desonide has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A 2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A 2 .
Pharmacokinetics
The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Occlusive dressing with hydrocortisone for up to 24 hours have not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.
Studies performed with desonide lotion indicate that they are in the low to medium range of potency as compared with other topical corticosteroids.
HOW SUPPLIED
Desonide Lotion USP, 0.05% is supplied in 59 mL and 118 mL bottles containing:
2 fl oz (59 mL) NDC 62332-550-59
4 fl oz (118 mL) NDC 62332-550-18
Storage Conditions: Store between 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Manufactured for:
Alembic Pharmaceuticals, Inc.
Bedminster, NJ 07921, USA
Manufactured by:
Alembic Pharmaceuticals Limited
(Derma Division),
Karakhadi, Vadodara 391450, India.
Mfg. License No.: G/25/2216
Revised: 07/2025
