Desonide

Desonide Cream 0.05% and Lotion 0.05% contain desonide (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 is C₂₄H₃₂O₆. It has the following structural formula:

desowen-structure-01

Desonide has the molecular weight of 416.51. It is a white to off white odorless powder which is soluble in methanol and practically insoluble in water.

Each gram of Desonide Cream contains 0.5 mg of desonide in a base of citric acid, emulsifying wax, isopropyl palmitate, polysorbate 60, potassium sorbate, propyl gallate, propylene glycol, purified water, sodium hydroxide, sorbic acid, stearic acid, and synthetic beeswax.

Each gram of Desonide Lotion contains 0.5 mg of desonide in a base of cetyl alcohol, edetate sodium, 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.

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 A₂ 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 A₂.

Desonide Cream and Lotion are low to medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.

Desonide Cream and Lotion are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

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.

Topically applied Desonide Cream and Lotion can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).

Desonide Cream or 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 Cream and Lotion should not be used with occlusive dressings.

Desonide Cream 0.05% is supplied in a tube containing:

15 g NDC 0472-0804-15

60 g NDC 0472-0804-60

Desonide Lotion 0.05% is supplied in bottles containing:

2 fl oz NDC 0472-0803-02

4 fl oz NDC 0472-0803-04

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

Marketed by:

Actavis Pharma, Inc.
Parsippany, NJ 07054 USA
Made in Canada
P53355-1 Rev. March 2018

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Actavis

NDC 0472-0804-60

Rx Only
For Topical Use Only.
Not for Ophthalmic Use.

Desonide

Cream 0.05% NET WT. 60 g

Marketed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA
Made in Canada

P53356-1

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

Usual dosage: Apply a small amount to affected areas 2 or 3 times daily.  See package insert for complete prescribing information.

Each gram contains 0.5 mg of the active ingredient desonide in a cream base consisting of the inactive ingredients citric acid, emulsifying wax, isopropyl palmitate, polysorbate 60, potassium sorbate, propyl gallate, propylene glycol, purified water, sodium hydroxide, sorbic acid, stearic acid and synthetic beeswax.

See carton closure for lot number and expiration date.

​

Rx Only NDC 0472-0803-04

Desonide

Lotion 0.05%

For Topical Use Only.
Not for Ophthalmic Use.

4 FL OZ

(118 mL)

SHAKE WELL BEFORE USING.

Usual dosage: Apply a small amount to affected areas 2 or 3 times daily. See package insert for complete prescribing information.

Contains: Active: desonide 0.05% w/w (0.5 mg/g). Inactive: cetyl alcohol, edetate sodium, 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. Lot number and expiration date on bottom of carton.

Store between 2° AND 30°C (36° AND 86°F).

Marketed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA
Made in Canada

P53346-0