NDC Code(s) : 0472-0804-15, 0472-0804-60
Packager : Actavis Mid Atlantic LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DesonideDesonide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0472-0804
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DESONIDE(UNII: J280872D1O)
(DESONIDE - UNII:J280872D1O) 		DESONIDE0.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
POLYSORBATE 60(UNII: CAL22UVI4M)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
PROPYL GALLATE(UNII: 8D4SNN7V92)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
WATER(UNII: 059QF0KO0R)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
SORBIC ACID(UNII: X045WJ989B)
STEARIC ACID(UNII: 4ELV7Z65AP)
YELLOW WAX(UNII: 2ZA36H0S2V)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0472-0804-151 in 1 CARTON
115 g in 1 TUBE
2NDC:0472-0804-601 in 1 CARTON
260 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA019048 08/01/2013

PRINCIPAL DISPLAY PANEL

deso carton 51342-0

Nosco

Desonide Cream 0.05% Net Wt. 15 g

LOT:

EXP:

actavis NDC 0472-0804-15

Desonide Cream 0.05% Rx Only

Net Wt. 15 g

NDC 0472-0804-15

Desonide Cream 0.05% Net Wt. 15 g

Distributed by: Actavis Mid Atlantic LLC, 1877 Kawai Road,

Lincolnton, NC 28092 USA

Manufactured by: DPT Laboratories, Ltd.

San Antonio, Texas 78215 USA

P51342-0 VC101639

Rev. 03/13

Net Wt. 15 g

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

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, and synthetic beeswax.

USUAL DOSAGE: See package insert for complete prescribing information.

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

See carton closure for lot number and expiration date.