Desonide by Aleor Dermaceuticals Limited DESONIDE ointment

Desonide by

Drug Labeling and Warnings

Desonide by is a Prescription medication manufactured, distributed, or labeled by Aleor Dermaceuticals Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MEDICATION GUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TUBE LABEL

Rx Only

NDC: 71589-005-15

Desonide Ointment, 0.05%

FOR EXTERNAL USE ONLY

NOT FOR OPHTHALMIC USE

NET WT 15 grams

CARTON LABEL

Rx Only

NDC: 71589-005-15

Desonide Ointment, 0.05%

FOR EXTERNAL USE ONLY

NOT FOR OPHTHALMIC USE

NET WT 15 grams

INGREDIENTS AND APPEARANCE

DESONIDE 
desonide ointment

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 71589-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DESONIDE (UNII: J280872D1O) (DESONIDE - UNII:J280872D1O)	DESONIDE	0.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71589-005-15	1 in 1 CARTON	11/02/2019
1		15 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 71589-005-60	1 in 1 CARTON	11/02/2019
2		60 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA212473	11/02/2019

Labeler - Aleor Dermaceuticals Limited (871411532)

Registrant - Aleor Dermaceuticals Limited (871411532)

Establishment
Name	Address	ID/FEI	Business Operations
Aleor Dermaceuticals Limited		871411532	MANUFACTURE(71589-005) , ANALYSIS(71589-005)