Econazole Nitrate Cream (Page 2 of 2)

HOW SUPPLIED

Econazole Nitrate Cream, 1% is supplied in tubes of 15 grams (NDC 47781-543-72), 30 grams (NDC 47781-543-73), and 85 grams (NDC 47781-543-86).

Store Econazole Nitrate Cream below 86°F.

To report SUSPECTED ADVERSE REACTIONS, contact Alvogen, Inc. at 1-866-770-3024 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch for voluntary reporting of adverse reactions.

Manufactured by:
WellSpring Pharma Services Inc.
Oakville, Ontario, L6H 1M5, Canada

Distributed by:
Alvogen, Inc.
Pine Brook, NJ 07058 USA

Product of Italy

PI543-02

Rev. 06/2018

NDC 47781-543 -72

Econazole Nitrate Cream

1%

Rx Only

15 Grams

15gtube
(click image for full-size original)

NDC 47781-543 -72

Econazole Nitrate Cream

1%

Rx Only

15 Grams

15gcarton
(click image for full-size original)
ECONAZOLE NITRATE CREAM
econazole nitrate cream cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47781-543
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Econazole Nitrate (Econazole) Econazole Nitrate 10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Pegoxol 7 Stearate
Peg-5 Oleate
Mineral Oil
Benzoic Acid
Butylated Hydroxyanisole
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47781-543-72 1 TUBE in 1 CARTON contains a TUBE
1 15 g in 1 TUBE This package is contained within the CARTON (47781-543-72)
2 NDC:47781-543-73 1 TUBE in 1 CARTON contains a TUBE
2 30 g in 1 TUBE This package is contained within the CARTON (47781-543-73)
3 NDC:47781-543-86 1 TUBE in 1 CARTON contains a TUBE
3 85 g in 1 TUBE This package is contained within the CARTON (47781-543-86)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018751 09/07/2017
Labeler — Alvogen Inc. (008057330)
Establishment
Name Address ID/FEI Operations
WellSpring Pharma Services Inc. 202519856 manufacture (47781-543), pack (47781-543), analysis (47781-543)

Revised: 06/2018 Alvogen Inc.

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