NDC Code(s) : 65628-051-01
Packager : CutisPharma, Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

FIRST BXN MouthwashDiphenhydramine, Lidocaine, Nystatin KIT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65628-051
Route of Administration ORAL DEA Schedule
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65628-051-011 in 1.0 CONTAINER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved other 09/08/2009

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - FIRST Mouthwash BXN, 237 mL

NDC 65628-051-01

Rx ONLY

FIRST BXN Mouthwash
Diphenhydramine, Lidocaine, and Nystatin Compounding Kit

Equivalent to active ingredients (Benadryl®, Xylocaine® 2% Viscous and Nystatin Oral Suspension 1:1:1 v/v/v) contained in Magic Mouthwash with Nystatin*


FOR PRESCRIPTION COMPOUNDING ONLY


8 FL OZ (237 mL) as dispensed


* This product is not manufactured or distributed by Pfizer, Inc., manufacturer of Benadryl® or AstraZeneca LP, manufacturer of Xylocaine® 2% Viscous


FIRST BXN Mouthwash Outer Package Display

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - FIRST Mouthwash Suspension II, Bottle 236 mL


FIRST® - BXN Mouthwash

FOR PRESCRIPTION COMPOUNDING ONLY

Distributed by:
 CUTISPHARMA, INC.
Woburn, MA 01801 USA

Manufactured by:
 ANI PHARMACEUTICALS, INC.
Gulfport, MS 39501 USA

NET CONTENTS
236 mL

ORAL SUSPENSION

CUTISPHARMA

FIRST Mouthwash Suspension II, Bottle 236 mL

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Diphenhydramine Hydrochloride, Bottle 0.2 Grams


FIRST® - BXN Mouthwash

FOR PRESCRIPTION COMPOUNDING ONLY

Diphenhydramine Hydrochloride USP (0.2 g)

Distributed by:
 CUTISPHARMA, Inc.
Woburn, MA 01801 USA

Repackaged by:
 MARLEX PHARMACEUTICALS, INC.
New Castle, DE 19720 USA

CUTISPHARMA
ORAL SUSPENSION

Diphenhydramine Hydrochloride, Bottle 0.2 Grams

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Lidocaine Hydrochloride, Bottle 1.6 Grams


FIRST® - BXN Mouthwash

FOR PRESCRIPTION COMPOUNDING ONLY
Lidocaine Hydrochloride USP (1.6 g)

Distributed by:
 CUTISPHARMA, INC.
Woburn, MA 01801 USA

Repackaged by:
 MARLEX PHARMACEUTICALS, INC.
New Castle, DE 19720 USA

CUTISPHARMA
ORAL SUSPENSION

Lidocaine Hydrochloride, Bottle 1.6 Grams

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Nystatin, Bottle 1.6 Grams


FIRST® - BXN Mouthwash

FOR PRESCRIPTION COMPOUNDING ONLY
Nystatin USP (1.6 g)

Distributed by:
 CUTISPHARMA, INC.
Woburn, MA 01801 USA

Repackaged by:
 MARLEX PHARMACEUTICALS, INC.
New Castle, DE 19720 USA

CUTISPHARMA
ORAL SUSPENSION

Nystatin, Bottle 1.6 Grams