Ertaczo (Page 3 of 3)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 60 g Carton

NDC 0187-5115-60

ERTACZO® (sertaconazole nitrate) cream, 2%

Rx only

For Topical Use Only — Not for Ophthalmic, Oral, or Intravaginal Use

Net Wt. 60 g

carton
(click image for full-size original)
ERTACZO sertaconazole nitrate cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0187-5115
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sertaconazole Nitrate (Sertaconazole) Sertaconazole Nitrate 20 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Ethylene Glycol
Glyceryl Isostearate
Light Mineral Oil
Methylparaben
Sorbic Acid
PEG-6 STEARATE
GLYCOL STEARATE
PEG-32 STEARATE
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0187-5115-60 1 TUBE in 1 CARTON contains a TUBE
1 60 g in 1 TUBE This package is contained within the CARTON (0187-5115-60)
2 NDC:0187-5115-02 18 TUBE in 1 CARTON contains a TUBE
2 2 g in 1 TUBE This package is contained within the CARTON (0187-5115-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021385 12/10/2003
Labeler — Bausch Health US, LLC (831922468)
Establishment
Name Address ID/FEI Operations
DPT Laboratories, Ltd. 832224526 MANUFACTURE (0187-5115)

Revised: 12/2020 Bausch Health US, LLC

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