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

Carton 60g
(click image for full-size original)

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

Carton 3.5g
(click image for full-size original)
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.

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