Desonide
DESONIDE Rx Onlycream 0.05%and lotion 0.05% For Dermatologic Use Only –Not for Ophthalmic Use –
ff5d4cd8-ab4d-4a9e-b84b-445c81eeea99
HUMAN PRESCRIPTION DRUG LABEL
Aug 26, 2025
Actavis Pharma, Inc.
DUNS: 119723554
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
desonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (11)
desonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (14)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL - Desonide Lotion
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
DESCRIPTION SECTION
DESCRIPTION:
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:
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.