DesOwen (Page 2 of 2)

OVERDOSAGE:

Topically applied DesOwen® (desonide cream and lotion) Cream and Lotion can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).

DOSAGE AND ADMINISTRATION:

DesOwen® Cream or Lotion should be applied to the affected areas as a thin film two or three times daily depending on the severity of the condition. SHAKE LOTION WELL BEFORE USING.

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

DesOwen® Cream and Lotion should not be used with occlusive dressings.

HOW SUPPLIED:

DesOwen® (desonide cream) Cream 0.05% is supplied in a tube containing:

60 g NDC 0299-5770-60

15 g NDC 0299-5770-15

DesOwen® (desonide lotion) Lotion 0.05% is supplied in bottles containing:

2 fl oz NDC 0299-5765-02

4 fl oz NDC 0299-5765-04

Storage Conditions: Store between 2° and 30°C (36° and 86°F).

Marketed by:
GALDERMA LABORATORIES, L.P.
Fort Worth, Texas 76177, USA
All trademarks are the property of their respective owners.
Made in CanadaP53306-0 Revised: April 2017

PACKAGE LABEL — Desowen Cream

P53307-0-deswoen-cream-carton-image
(click image for full-size original)

NDC 0299-5770-60

Rx Only
For Topical Use Only.
Not for Ophthalmic Use.

DesOwen®

(desonide cream)

Cream 0.05% NET WT. 60 g

GALDERMA

Marketed by:
GALDERMA LABORATORIES, L.P.
Fort Worth, Texas 76177 USA
All trademarks are the property of their respective owners.
Made in Canada
P53307-0

Store between 2° and 30°C (35° and 86°F).

Usual dosage: Apply a small amount to affected areas 2 or 3 times daily. See package insert for complete prescribing information.

Each gram contains 0.5 mg of the active ingredient desonide in a cream base consisting of the inactive ingredients 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.

See carton closure for lot number and expiration date.

PACKAGE Label — Desown Lotion

P53311-0-desowen-lotion-carton-image
(click image for full-size original)

Rx Only NDC 0299-5765-04

DesOwen®

(desonide lotion)

LOTION 0.05%

4 FL OZ

(118 mL)

For Topical Use Only.
Not for ophthalmic Use

GALDERMA

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:
GALDERMA LABORATORIES, L.P.
Fort Worth, Texas
76177 USA
Made in Canada.
All trademarks are the property of their respective owners.P53311-0

DESOWEN desonide cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0299-5770
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
ANHYDROUS CITRIC ACID
Isopropyl palmitate
Polysorbate 60
Potassium sorbate
Propyl gallate
Propylene glycol
Water
Sodium hydroxide
Sorbic Acid
Stearic Acid
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0299-5770-60 1 TUBE in 1 CARTON contains a TUBE
1 60 g in 1 TUBE This package is contained within the CARTON (0299-5770-60)
2 NDC:0299-5770-15 1 TUBE in 1 CARTON contains a TUBE
2 15 g in 1 TUBE This package is contained within the CARTON (0299-5770-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019048 12/14/1984
DESOWEN desonide lotion
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0299-5765
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
Cetyl alcohol
Edetate sodium
Glyceryl Monostearate
Light Mineral Oil
Methylparaben
Propylene glycol
Propylparaben
Water
Sodium lauryl sulfate
Sorbitan monostearate
Stearyl alcohol
ANHYDROUS CITRIC ACID
Sodium hydroxide
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0299-5765-02 59 g in 1 BOTTLE None
2 NDC:0299-5765-04 1 BOTTLE in 1 CARTON contains a BOTTLE
2 118 g in 1 BOTTLE This package is contained within the CARTON (0299-5765-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA072354 07/15/1988
Labeler — Galderma Laboratories, L.P. (047350186)
Establishment
Name Address ID/FEI Operations
DPT Laboratories, Ltd. 832224526 MANUFACTURE (0299-5770), manufacture (0299-5765)
Establishment
Name Address ID/FEI Operations
G Production Inc. 251676961 manufacture (0299-5765), manufacture (0299-5770)

Revised: 01/2019 Galderma Laboratories, L.P.

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