MedPath
FDA Product

CICLOPIROX

Product approved by U.S. Food and Drug Administration (US)

Basic Information

CICLOPIROX

63629-8622

Regulatory Information

63629-8622

ANDA078266

C73584

February 22, 2022

USA

Ciclopirox Gel, 0.77%

HUMAN PRESCRIPTION DRUG LABEL

103

Company Information

171714327

Active Ingredients

CICLOPIROX

Quantity: 7.7 mg in 1 g

Code: 19W019ZDRJ

Class Code: ACTIB

WATER

Code: 059QF0KO0R

Class Code: IACT

ISOPROPYL ALCOHOL

Code: ND2M416302

Class Code: IACT

OCTYLDODECANOL

Code: 461N1O614Y

Class Code: IACT

CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)

Code: 4Q93RCW27E

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

DOCUSATE SODIUM

Code: F05Q2T2JA0

Class Code: IACT

PEG/PPG-18/18 DIMETHICONE

Code: 9H0AO7T794

Class Code: IACT

Active Moieties

CICLOPIROX

Code: 19W019ZDRJ

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