NDC Code(s) : 42192-714-01
Packager : Acella Pharmaceuticals, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CiclopiroxCiclopirox KIT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42192-714
Route of Administration DEA Schedule
Inactive Ingredients
Ingredient Name Strength
ETHYL ACETATE(UNII: 76845O8NMZ)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
BUTYL ESTER OF METHYL VINYL ETHER-MALEIC ANHYDRIDE COPOLYMER (125 KD)(UNII: 389H2R62BD)
WATER(UNII: 059QF0KO0R)
UREA(UNII: 8W8T17847W)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
EDETATE DISODIUM(UNII: 7FLD91C86K)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
HYDROXYETHYL CELLULOSE (6500 MPA.S AT 2%)(UNII: 2Q40985DRM)
EUCALYPTUS OIL(UNII: 2R04ONI662)
MENTHOL(UNII: L7T10EIP3A)
CAMPHOR (NATURAL)(UNII: N20HL7Q941)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42192-714-011 in 1 CARTON 10/10/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/10/2011

LABELER - Acella Pharmaceuticals, LLC(825380939)

Establishment
Name Address ID/FEI Business Operations
Acella Pharmaceuticals, LLC 825380939 MANUFACTURE(42192-714)

PRINCIPAL DISPLAY PANEL

NDC 42192-714-01

Ciclopirox
Treatment Kit

Ciclopirox Topical Solution, 8% (Nail Lacquer)
Topical Toe Freshener

Rx Only

Contains:
6.6 mL bottle of Ciclopirox Topical
Solution, 8% (nail lacquer)
1 - 28 mL bottle Topical Toe Freshener

Acella
PHARMACEUTICALS, LLC

Principal Display Panel - 90 g Tube Carton