Xepi (Page 3 of 3)

PRINCIPAL DISPLAY PANEL — 30 g Tube Carton

Xepi
(ozenoxacin) Cream, 1%

NDC 70363-011-30

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

30g Rx Only

Cutanea Life Sciences, Inc.

PRINCIPAL DISPLAY PANEL -- 30 g Tube Carton
(click image for full-size original)
XEPI
ozenoxacin cream
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
Packaging
# 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. (791866960)

Revised: 02/2019 Cutanea Life Sciences, Inc.

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