DESONIDE

6 ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In controlled clinical studies of 425 Desonide Gel, 0.05%-treated subjects and 157 Vehicle-treated subjects, adverse events occurred at the application site in 3% of subjects treated with Desonide Gel, 0.05% and the incidence rate was not higher compared with vehicle-treated subjects. The most common local adverse events in Desonide Gel, 0.05% treated subjects were application site burning in 1% (4/425) and rash in 1% (3/425) followed by application site pruritus in <1% (2/425). Adverse events that resulted in premature discontinuation of study drug in Desonide Gel, 0.05% treated subjects were telangiectasia and worsening of atopic dermatitis in one subject each. Additional adverse events observed during clinical trials for patients treated with Desonide Gel, 0.05% included headache in 2% (8/425) compared with 1% (2/157) in those treated with vehicle. The following additional local adverse reactions have been reported infrequently with topical corticosteroids. 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. The most common adverse reactions (incidence ≥ 1%) are headache and application site burning. (6) To report SUSPECTED ADVERSE REACTIONS, contact Cintex Services, LLC at 1-855-899-4237 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

4 CONTRAINDICATIONS Desonide Gel, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. History of hypersensitivity to any of the components of the preparation.

11 DESCRIPTION Desonide Gel, 0.05% contains 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. Chemically, desonide is C 24 H 32 O 6 . It has the following structural formula: Desonide has the molecular weight of 416.52. It is a white to off-white odorless powder which is soluble in methanol and practically insoluble in water. Each gram of Desonide Gel, 0.05% contains 0.5 mg of desonide in an aqueous gel base of purified water, glycerin, propylene glycol, edetate disodium, methylparaben, propylparaben, sodium hydroxide, and Carbopol ® 974 P. structure

2 DOSAGE AND ADMINISTRATION Apply a thin layer to the affected areas two times daily and rub in gently. Discontinue use when control is achieved. If no improvement is seen within 4 weeks, reassessment of diagnosis may be necessary. Treatment beyond 4 consecutive weeks is not recommended. Do not use with occlusive dressings. Avoid contact with eyes or other mucous membranes. For topical use only. Not for oral, ophthalmic, or intravaginal use. • Apply as a thin layer to the affected areas two times daily and rub in gently. ( 2 ) • Therapy should be discontinued when control is achieved. ( 2 ) • If no improvement is seen within 4 weeks, reassessment of diagnosis may be necessary. ( 2 ) • Should not be used with occlusive dressings. ( 2 ) • Treatment beyond 4 consecutive weeks is not recommended. ( 2 ) • For topical use only. Not for oral, ophthalmic, or intravaginal use. ( 2 )

1 INDICATIONS AND USAGE Desonide Gel, 0.05% is indicated for the treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. Patients should be instructed to use Desonide Gel, 0.05% for the minimum amount of time as necessary to achieve the desired results because of the potential for Desonide Gel, 0.05% to suppress the hypothalamicpituitary-adrenal (HPA) axis [see Warnings and Precautions ( 5.1 )]. Treatment should not exceed 4 consecutive weeks [see Dosage and Administration ( 2 )]. Desonide Gel, 0.05% is a corticosteroid indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. ( 1 )

10 OVERDOSAGE Topically applied Desonide Gel, 0.05% can be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions ( 5.1 )] .

12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action The mechanism of action of desonide is unknown. 12.2 Pharmacodynamics In an HPA axis suppression study, one of 37 (3%) pediatric subjects, 6 months to 6 years old, with moderate to severe atopic dermatitis covering at least 35% body surface area who applied Desonide Gel, 0.05% experienced suppression of the adrenal glands following 4 weeks of therapy [see Warnings And Precautions ( 5.1 ) and Use In Specific Populations ( 8.4 )] . A follow-up evaluation of the subject’s adrenal axis was not performed; it is unknown whether the suppression was reversible. 12.3 Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including product formulation and the integrity of the epidermal barrier. Occlusion, inflammation and/or other disease processes in the skin may also increase percutaneous absorption. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. They are metabolized primarily in the liver and then are excreted by the kidneys. Some corticosteroids and their metabolites are also excreted in the bile.

12.1 Mechanism of Action The mechanism of action of desonide is unknown.

12.2 Pharmacodynamics In an HPA axis suppression study, one of 37 (3%) pediatric subjects, 6 months to 6 years old, with moderate to severe atopic dermatitis covering at least 35% body surface area who applied Desonide Gel, 0.05% experienced suppression of the adrenal glands following 4 weeks of therapy [see Warnings And Precautions ( 5.1 ) and Use In Specific Populations ( 8.4 )] . A follow-up evaluation of the subject’s adrenal axis was not performed; it is unknown whether the suppression was reversible.

12.3 Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including product formulation and the integrity of the epidermal barrier. Occlusion, inflammation and/or other disease processes in the skin may also increase percutaneous absorption. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. They are metabolized primarily in the liver and then are excreted by the kidneys. Some corticosteroids and their metabolites are also excreted in the bile.

20200731

3

3 DOSAGE FORMS AND STRENGTHS Gel, 0.05%; (0.5mg/g) desonide in a translucent to opaque gel Gel, 0.05%; (0.5mg/g) desonide in a translucent to opaque gel

DESONIDE Desonide CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) GLYCERIN WATER SODIUM HYDROXIDE DESONIDE DESONIDE PROPYLENE GLYCOL EDETATE DISODIUM METHYLPARABEN PROPYLPARABEN

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Systemic long-term animal studies have not been performed to evaluate the carcinogenic potential of desonide or its effect on fertility. In a 26-week dermal carcinogenicity study conducted in transgenic (Tg.AC) mice, once daily application of 0.005% to 0.05% Desonide Gel 0.05 % significantly increased the incidence of papillomas at the treatment site in males and females compared to their respective control animals. The clinical relevance of these findings in animals to humans is not clear. Desonide revealed no evidence of mutagenic potential based on the results of an in vitro genotoxicity test (Ames assay) and an in vivo genotoxicity test (mouse micronucleus assay). Desonide was positive without S9 activation and was equivocal with S9 activation in an in vitro mammalian cell mutagenesis assay (L5178YITK+ mouse lymphoma assay). A dose response trend was not noted in this assay.

13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Systemic long-term animal studies have not been performed to evaluate the carcinogenic potential of desonide or its effect on fertility. In a 26-week dermal carcinogenicity study conducted in transgenic (Tg.AC) mice, once daily application of 0.005% to 0.05% Desonide Gel 0.05 % significantly increased the incidence of papillomas at the treatment site in males and females compared to their respective control animals. The clinical relevance of these findings in animals to humans is not clear. Desonide revealed no evidence of mutagenic potential based on the results of an in vitro genotoxicity test (Ames assay) and an in vivo genotoxicity test (mouse micronucleus assay). Desonide was positive without S9 activation and was equivocal with S9 activation in an in vitro mammalian cell mutagenesis assay (L5178YITK+ mouse lymphoma assay). A dose response trend was not noted in this assay.

ANDA202470

DESONIDE

Desonide

24470-920

HUMAN PRESCRIPTION DRUG

TOPICAL

PRINCIPAL DISPLAY PANEL FOR DESONIDE GEL, 0.05% Rx Only Manufactured for: Cintex Services, LLC 9330 LBJ Freeway Suite 900 Dallas, TX 75243 v1 Rev. 05/16 2000086 [00] Carton.jpg

17 PATIENT COUNSELING INFORMATION Patients using topical corticosteroids should receive the following information and instructions: This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. This medication should not be used for any disorder other than that for which it was prescribed. Unless directed by the physician, the treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive. Unless directed by a physician, this medication should not be used on the underarm or groin areas of pediatric patients. Parents of pediatric patients should be advised not to use Desonide Gel, 0.05% in the treatment of diaper dermatitis. Desonide Gel, 0.05% should not be applied in the diaper area, as diapers or plastic pants may constitute occlusive dressing [see Dosage and Administration ( 2 )] . Patients should report to their physician any signs of local adverse reactions. Other corticosteroid-containing products should not be used with Desonide Gel, 0.05% without first consulting with the physician. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 4 weeks, contact the physician.

14 CLINICAL STUDIES In two randomized vehicle-controlled clinical studies, subjects 3 months to 18 years of age with mild to moderate atopic dermatitis were treated twice daily for 4 weeks with either Desonide Gel, 0.05% or vehicle. Treatment success was defined as achieving clear or almost clear on the Investigator’s Global Severity Score (IGSS) with at least a 2-point change (decrease) from the subject’s baseline IGSS when compared to the Week 4 IGSS. The results of the 2 clinical trials are summarized in Table 1: Table 1: Subjects Achieving Treatment Success Clinical Trial 1 Desonide Gel, 0.05% N = 289 Vehicle N = 92 128 (44%) 13 (14%) Clinical Trial 2 Desonide Gel, 0.05% N = 136 Vehicle N = 65 38 (28%) 4 (6%)

8 USE IN SPECIFIC POPULATIONS Safety and effectiveness of Desonide Gel, 0.05% in pediatric patients less than 3 months of age have not been evaluated, and therefore its use in this age group is not recommended. ( 8.4 ) See 17 for PATIENT COUNSELING INFORMATION. Revised: 05/2016 8.1 Pregnancy Teratogenic effects: Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Therefore, Desonide Gel, 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. No reproductive studies in animals have been performed with Desonide Gel, 0.05%. Dermal embryofetal development studies were conducted in rats and rabbits with a desonide cream, 0.05% formulation. Topical doses of 0.2, 0.6, and 2.0 g cream/kg/day of a desonide cream, 0.05% formulation or 2.0 g/kg of the cream base were administered topically to pregnant rats (gestational days 6-15) and pregnant rabbits (gestational days 6-18). Maternal body weight loss was noted at all dose levels of the desonide cream, 0.05% formulation in rats and rabbits. Teratogenic effects characteristic of corticosteroids were noted in both species. The desonide cream, 0.05% formulation was teratogenic in rats at topical doses of 0.6 and 2.0 g cream/kg/day and in rabbits at a topical dose of 2.0 g cream/kg/day. No teratogenic effects were noted for the desonide cream, 0.05% formulation at a topical dose of 0.2 g cream/kg/day in rats and 0.6 g cream/kg/day in rabbits. These doses (0.2 g cream/kg/day and 0.6 g cream/kg/day) are similar to the maximum recommended human dose based on body surface area comparisons. Teratogenic effects: Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Therefore, Desonide Gel, 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. No reproductive studies in animals have been performed with Desonide Gel, 0.05%. Dermal embryofetal development studies were conducted in rats and rabbits with a desonide cream, 0.05% formulation. Topical doses of 0.2, 0.6, and 2.0 g cream/kg/day of a desonide cream, 0.05% formulation or 2.0 g/kg of the cream base were administered topically to pregnant rats (gestational days 6-15) and pregnant rabbits (gestational days 6-18). Maternal body weight loss was noted at all dose levels of the desonide cream, 0.05% formulation in rats and rabbits. Teratogenic effects characteristic of corticosteroids were noted in both species. The desonide cream, 0.05% formulation was teratogenic in rats at topical doses of 0.6 and 2.0 g cream/kg/day and in rabbits at a topical dose of 2.0 g cream/kg/day. No teratogenic effects were noted for the desonide cream, 0.05% formulation at a topical dose of 0.2 g cream/kg/day in rats and 0.6 g cream/kg/day in rabbits. These doses (0.2 g cream/kg/day and 0.6 g cream/kg/day) are similar to the maximum recommended human dose based on body surface area comparisons. 8.3 Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Desonide Gel, 0.05% is administered to a nursing woman. 8.4 Pediatric Use Safety and effectiveness of Desonide Gel, 0.05% in pediatric patients less than 3 months of age have not been evaluated, and therefore its use in this age group is not recommended. The effect of Desonide Gel, 0.05% on HPA axis function was investigated in pediatric subjects, with atopic dermatitis covering at least 35% of their body, who were treated with Desonide Gel, 0.05% twice daily for 4 weeks. One of 37 subjects (3%) displayed adrenal suppression after 4 weeks of use, based on the cosyntropin stimulation test [see Warnings and Precautions ( 5.1 )] . In controlled clinical studies in subjects 3 months to 18 years of age, 425 subjects were treated with Desonide Gel, 0.05% and 157 subjects were treated with vehicle [see Adverse Reactions ( 6 ) and Clinical Studies ( 14 )] . 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 when they are treated with topical corticosteroids. They are therefore also at greater risk of glucocorticosteroid insufficiency after withdrawal of treatment and of Cushing’s syndrome while on 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. 8.5 Geriatric Use Clinical studies of Desonide Gel, 0.05% did not include patients aged 65 and older to determine if they respond differently than younger patients. Treatment of this patient population should reflect the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

16 HOW SUPPLIED/STORAGE AND HANDLING Desonide Gel, 0.05% is a translucent to opaque gel supplied in 60g tubes in cartons containing 1x 60g tube (NDC 24470-920-60). Storage: Store at controlled room temperature: 25°C (77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Keep out of reach of children.