DESONATE (Page 3 of 3)

PRINCIPAL DISPLAY PANEL FOR DESONATE^® (DESONIDE) GEL

NDC 50222-504-60

Desonate^® (desonide) Gel 0.05%

Rx only

For Topical Use Only

Not For Ophthalmic, Oral, or Intravaginal Use

Net Wt. 60 g

PRINCIPAL DISPLAY PANEL FOR DESONATE^® (DESONIDE) GEL PHYSICIAN SAMPLE

NDC 50222-504-91

SAMPLE — NOT FOR SALE

Desonate^® (desonide) Gel 0.05%

Rx only

For Topical Use Only

Not For Ophthalmic, Oral, or Intravaginal Use

Net Wt. 3.5 g

DESONATE desonide gel

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50222-504 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DESONIDE (DESONIDE) DESONIDE 0.5 mg in 1 g

Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) EDETATE DISODIUM GLYCERIN METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN SODIUM HYDROXIDE WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50222-504-60 1 TUBE in 1 CARTON contains a TUBE 1 60 g in 1 TUBE This package is contained within the CARTON (50222-504-60) 2 NDC:50222-504-91 1 TUBE in 1 CARTON contains a TUBE 2 3.5 g in 1 TUBE This package is contained within the CARTON (50222-504-91)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021844 10/01/2018

Labeler — LEO Pharma Inc. (832692615)

Establishment
Name	Address	ID/FEI	Operations
Contract Pharmaceutical Limited		248761249	MANUFACTURE (50222-504)

Revised: 06/2021 LEO Pharma Inc.