DesOwen Description

DesOwen® 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:

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 DesOwen® 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 DesOwen® 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.

DesOwen - 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 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.

Indications and Usage for DesOwen

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

Contraindications

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

Precautions

Adverse Reactions/Side Effects

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.

Overdosage

Topically applied DesOwen® (desonide cream and lotion) Cream and Lotion can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).

DesOwen Dosage and Administration

DesOwen® 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.

DesOwen® Cream and Lotion should not be used with occlusive dressings.

How is DesOwen supplied

DesOwen® (desonide cream) Cream 0.05% is supplied in a tube containing:

60 g NDC 0299-5770-60

15 g NDC 0299-5770-15

DesOwen® (desonide lotion) Lotion 0.05% is supplied in bottles containing:

2 fl oz NDC 0299-5765-02

4 fl oz NDC 0299-5765-04

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

Marketed by:
GALDERMA LABORATORIES, L.P.
Fort Worth, Texas 76177, USA

All trademarks are the property of their respective owners.

Made in Canada

P53306-0 Revised: April 2017

PACKAGE LABEL - Desowen Cream

NDC 0299-5770-60

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

DesOwen®

(desonide cream)

Cream 0.05% NET WT. 60 g

GALDERMA

Marketed by:
GALDERMA LABORATORIES, L.P.
Fort Worth, Texas 76177 USA
All trademarks are the property of their respective owners.
Made in Canada
P53307-0

Store between 2° and 30°C (35° 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.

PACKAGE Label - Desown Lotion

Rx Only NDC 0299-5765-04

DesOwen®

(desonide lotion)

LOTION 0.05%

4 FL OZ

(118 mL)

For Topical Use Only.
Not for ophthalmic Use

GALDERMA

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:
GALDERMA LABORATORIES, L.P.
Fort Worth, Texas
76177 USA
Made in Canada.
All trademarks are the property of their respective owners.
P53311-0