ESTRACE (Page 7 of 7)

HOW SUPPLIED

ESTRACE ® (estradiol vaginal cream, USP, 0.01%).

N 0430-3754-14: Tube containing 1 ½ oz (42.5 gram) with a calibrated plastic applicator for delivery of 1, 2, 3, or 4 gram.

NOTE: The number of doses per tube will vary with dosage requirements and patient handling.

Store at room temperature 20° to 25°C (59° to 77°F). Protect from temperatures in excess of 40° C (104° F).

Distributed by:

Allergan USA, Inc.

Madison, NJ 07940

© 2018 Allergan. All rights reserved.

Allergan^® and its design are trademarks of Allergan, Inc.

ESTRACE^® is a registered trademark of Allergan Pharmaceuticals International Limited.

Revised: 06/2018

v1.0PPI3754

PRINCIPAL DISPLAY PANEL

NDC 0430-3754-14
ESTRACE CREAM
(estradiol vaginal cream, USP, 0.01%)
Rx OnlyNET WT 1 ½ OZ (42.5 G)

ESTRACE estradiol cream

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0430-3754 Route of Administration VAGINAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ESTRADIOL (ESTRADIOL) ESTRADIOL 0.1 mg in 1 g

Inactive Ingredients Ingredient Name Strength WATER PROPYLENE GLYCOL STEARYL ALCOHOL CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES HYPROMELLOSE 2208 (4000 MPA.S) SODIUM LAURYL SULFATE METHYLPARABEN EDETATE DISODIUM TERT-BUTYLHYDROQUINONE CERESIN

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0430-3754-14 36 CARTON in 1 CASE contains a CARTON 1 1 TUBE, WITH APPLICATOR in 1 CARTON This package is contained within the CASE (0430-3754-14) and contains a TUBE, WITH APPLICATOR 1 42.5 g in 1 TUBE, WITH APPLICATOR This package is contained within a CARTON and a CASE (0430-3754-14)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA086069 07/01/2001

Labeler — Allergan, Inc. (144796497)

Establishment
Name	Address	ID/FEI	Operations
Aspen Oss B.V.		491017488	API MANUFACTURE (0430-3754)

Establishment
Name	Address	ID/FEI	Operations
Aspen Oss B.V.		491013870	API MANUFACTURE (0430-3754)

Establishment
Name	Address	ID/FEI	Operations
Contract Pharmaceuticals Limited Canada		248761249	MANUFACTURE (0430-3754)

Revised: 06/2018 Allergan, Inc.