Econazole Nitrate (Page 2 of 2)

PRINCIPAL DISPLAY PANEL — 30 g Tube Label

NDC 68788-7406-3

ECONAZOLE NITRATE
CREAM 1%

30 grams

Rx ONLY

FOR TOPICAL USE ONLY
NOT FOR OPHTHALMIC USE

Econazole Nitrate Cream, 1%
(click image for full-size original)
ECONAZOLE NITRATE
econazole nitrate cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68788-7406(NDC:52565-022)
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:68788-7406-3 1 TUBE in 1 CARTON contains a TUBE
1 30 g in 1 TUBE This package is contained within the CARTON (68788-7406-3)
2 NDC:68788-7406-1 15 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076574 06/06/2018
Labeler — Preferred Pharmaceuticals Inc. (791119022)
Registrant — Preferred Pharmaceuticals Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals Inc. 791119022 RELABEL (68788-7406)

Revised: 05/2020 Preferred Pharmaceuticals Inc.

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