PRINCIPAL DISPLAY PANEL — 30 g Tube Carton
(ozenoxacin) Cream, 1%
For Topical Use Only
Not for Ophthalmic, Oral, Intranasal,
or Intravaginal Use
30g Rx Only
Cutanea Life Sciences, Inc.
| XEPI |
|Product Information |
|Product Type ||HUMAN PRESCRIPTION DRUG ||Item Code (Source) ||NDC:70363-011 |
|Route of Administration ||TOPICAL ||DEA Schedule || |
|Active Ingredient/Active Moiety |
|Ingredient Name ||Basis of Strength ||Strength |
|OZENOXACIN (OZENOXACIN) ||OZENOXACIN ||10 mg in 1 g |
|Product Characteristics |
|Color ||WHITE ||Score || |
|Shape || ||Size || |
|Flavor || ||Imprint Code || |
|Contains || |
|# ||Item Code ||Package Description ||Multilevel Packaging |
| 1 ||NDC:70363-011-30 ||1 TUBE in 1 BOX ||contains a TUBE |
| 1 || ||30 g in 1 TUBE ||This package is contained within the BOX (70363-011-30) |
| 2 ||NDC:70363-011-04 ||1 TUBE in 1 BOX ||contains a TUBE |
| 2 || ||3 g in 1 TUBE ||This package is contained within the BOX (70363-011-04) |
| Marketing Information |
|Marketing Category ||Application Number or Monograph Citation ||Marketing Start Date ||Marketing End Date |
|NDA ||NDA208945 ||10/05/2018 || |
|Labeler — Cutanea Life Sciences, Inc.
Revised: 02/2019 Cutanea Life Sciences, Inc.
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