NDC Code(s) : 0145-0020-03, 0145-0020-02, 0145-0020-62
Packager : Stiefel Laboratories, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Fabiortazarotene AEROSOL, FOAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0145-0020
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TAZAROTENE(UNII: 81BDR9Y8PS)
(TAZAROTENE - UNII:81BDR9Y8PS) 		TAZAROTENE1 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
CETEARETH-12(UNII: 7V4MR24V5P)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
DIISOPROPYL ADIPATE(UNII: P7E6YFV72X)
LIGHT MINERAL OIL(UNII: N6K5787QVP)
POTASSIUM CITRATE(UNII: EE90ONI6FF)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
WATER(UNII: 059QF0KO0R)
SORBIC ACID(UNII: X045WJ989B)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0145-0020-031 in 1 CARTON 09/04/2013
150 g in 1 CAN Type 0: Not a Combination Product
2NDC:0145-0020-021 in 1 CARTON 09/04/2013
2100 g in 1 CAN Type 0: Not a Combination Product
3NDC:0145-0020-6250 g in 1 CAN Type 0: Not a Combination Product09/04/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202428 09/04/2013 09/30/2018

PRINCIPAL DISPLAY PANEL

PRODUCT DISPLAY PANEL

NDC 0145-0020-03

Fabior®

(tazarotene) Foam, 0.1%

50 grams

For topical use only

Store upright

Rx only

©2014 Stiefel Laboratories, Inc.

Rev. 5/14

10000000124106

Fabior 50 g carton