FABIOR (Page 5 of 5)

PRINCIPAL DISPLAY PANEL — 50 gram Can Carton

NDC 51862-295 -50

Fabior®
(tazarotene) Foam,
0.1%

50 grams

Rx only
For topical use only

STORE UPRIGHT

mayne pharma

Recyclable
Aluminum
Container

PRINCIPAL DISPLAY PANEL -- 50 gram Can Carton
(click image for full-size original)
FABIOR
tazarotene aerosol, foam
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51862-295
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
tazarotene (tazarotene) tazarotene 1 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
CETEARETH-12
ANHYDROUS CITRIC ACID
DIISOPROPYL ADIPATE
LIGHT MINERAL OIL
POTASSIUM CITRATE
POTASSIUM SORBATE
WATER
SORBIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51862-295-50 1 CAN in 1 CARTON contains a CAN
1 50 g in 1 CAN This package is contained within the CARTON (51862-295-50)
2 NDC:51862-295-10 1 CAN in 1 CARTON contains a CAN
2 100 g in 1 CAN This package is contained within the CARTON (51862-295-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202428 03/10/2017
Labeler — Mayne Pharma LLC (867220261)
Establishment
Name Address ID/FEI Operations
DPT Laboratories, Ltd. 832224526 ANALYSIS (51862-295), MANUFACTURE (51862-295)
Establishment
Name Address ID/FEI Operations
DPT Laboratories, Ltd. 832224591 PACK (51862-295), LABEL (51862-295)

Revised: 03/2017 Mayne Pharma LLC

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