NDC Code(s) : 54868-6291-0
Packager : Physicians Total Care, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CLOBETASOL PROPIONATE clobetasol propionate AEROSOL, FOAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-6291(NDC:66993-888)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOBETASOL PROPIONATE(UNII: 779619577M)
(CLOBETASOL - UNII:ADN79D536H) 		CLOBETASOL PROPIONATE0.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CETYL ALCOHOL(UNII: 936JST6JCN)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
ALCOHOL(UNII: 3K9958V90M)
POLYSORBATE 60(UNII: CAL22UVI4M)
POTASSIUM CITRATE(UNII: EE90ONI6FF)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
WATER(UNII: 059QF0KO0R)
STEARYL ALCOHOL(UNII: 2KR89I4H1Y)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54868-6291-050 g in 1 CAN
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021142 08/16/2011

LABELER - Physicians Total Care, Inc.(194123980)

Establishment
Name Address ID/FEI Business Operations
Physicians Total Care, Inc. 194123980 relabel, repack

PRINCIPAL DISPLAY PANEL

NDC 54868-6291-0

Clobetasol Propionate 50g label

Clobetasol Propionate Foam, 0.05%

Rx Only

Net Wt. 50 g

FOR DERMATOLOGIC USE ONLY.

NOT FOR OPHTHALMIC USE.

Invert can and then press firmly to dispense

Dosage: Use only as prescribed by your physician. See package insert for full prescribing information.

Warning: FLAMMABLE. AVOID FIRE, FLAME, OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION.

Keep away from eyes. Keep out of reach of children.

Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120oF (49oC).

Store at controlled room temperature, 68o – 77oF (20o – 25oC).

CFC FREE

Description: Clobetasol propionate foam, 0.05% contains 0.5 mg clobetasol propionate, USP, per gram in a thermolabile hydroethanolic foam vehicle consisting of cetyl alcohol, citric acid, ethanol (60%), polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant.