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.

Allergan

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)

PRINCIPAL DISPLAY PANEL
NDC 0430-3754-14
ESTRACE CREAM
(estradiol vaginal cream, USP, 0.01%)
Rx Only
NET WT 1 ½ OZ (42.5 G)
(click image for full-size original)
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.

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