NDC Code(s) : 43538-520-90, 43538-521-90
Packager : Medimetriks Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ciclodanciclopirox olamine CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43538-520
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ciclopirox olamine(UNII: 50MD4SB4AP)
(ciclopirox - UNII:19W019ZDRJ) 		ciclopirox7.7 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
benzyl alcohol(UNII: LKG8494WBH)
cetyl alcohol(UNII: 936JST6JCN)
lactic acid(UNII: 33X04XA5AT)
light mineral oil(UNII: N6K5787QVP)
myristyl alcohol(UNII: V42034O9PU)
octyldodecanol(UNII: 461N1O614Y)
polysorbate 60(UNII: CAL22UVI4M)
water(UNII: 059QF0KO0R)
sorbitan monostearate(UNII: NVZ4I0H58X)
stearyl alcohol(UNII: 2KR89I4H1Y)
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43538-520-901 in 1 CARTON
190 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077364 06/15/2012
Ciclodanciclopirox olamine KIT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43538-521
Route of Administration DEA Schedule
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43538-521-901 in 1 CARTON
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077364 06/15/2012

PRINCIPAL DISPLAY PANEL

NDC 43538-520-90

Rx Only
Ciclodan ® Cream
(CICLOPIROX OLAMINE CREAM USP, 0.77%)

FOR DERMATOLIGIC USE ONLY
NOT FOR USE IN EYES

Net Wt. 90 g

MEDIMETRIKS
PHARMACEUTICALS, INC.

Principal Display Panel - 90 g Tube Carton

PRINCIPAL DISPLAY PANEL

NDC 43538-521-90

Rx Only
Ciclodan ® Cream
(CICLOPIROX OLAMINE CREAM USP, 0.77%)
KIT

CONTENTS:
1 - Ciclodan® (Ciclopirox Olamine Cream USP, 0.77) Cream - Net wt. 90 g
1 - Rehyla™ Hair & Body Cleanser Bottle - Net wt. 16 oz. (454 g)

MEDIMETRIKS
PHARMACEUTICALS, INC.

Principal Display Panel - Kit Carton