NDC Code(s) : 54868-3584-0, 54868-3584-1, 54868-3584-2, 54868-3584-3
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 CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-3584(NDC:50383-267)
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)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
GLYCOL STEARATE(UNII: 0324G66D0E)
LANOLIN(UNII: 7EV65EAW6H)
METHYLPARABEN(UNII: A2I8C7HI9T)
POLYOXYL 8 STEARATE(UNII: 2P9L47VI5E)
POLYSORBATE 60(UNII: CAL22UVI4M)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
WATER(UNII: 059QF0KO0R)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
STEARYL ALCOHOL(UNII: 2KR89I4H1Y)
PETROLATUM(UNII: 4T6H12BN9U)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54868-3584-01 in 1 CARTON
130 g in 1 TUBE
2NDC:54868-3584-11 in 1 CARTON
245 g in 1 TUBE
3NDC:54868-3584-21 in 1 CARTON
315 g in 1 TUBE
4NDC:54868-3584-31 in 1 CARTON
460 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074220 05/02/1997

LABELER - Physicians Total Care, Inc.(194123980)

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

PRINCIPAL DISPLAY PANEL

Clobetasol Propionate Cream, USP, 0.05%

30 gram

For dermatologic use only.

Not for ophthalmic use.

Rx only

 Image of 30 grams package label