CICLOPIROX 3% / ITRACONAZOLE 5% / UREA 20%- ciclopirox 3% / itraconazole 5% / urea 20% cream 
Sincerus Florida, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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CICLOPIROX 3% / ITRACONAZOLE 5% / UREA 20%

Directions for use

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Sincerus Florida, LLC. Adverse reactions

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Active, inactive

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NDC 72934- 2044-2 CICLOPIROX 3% / ITRACONAZOLE 5% / UREA 20%. Cream 30 gm

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CICLOPIROX 3% / ITRACONAZOLE 5% / UREA 20% 
ciclopirox 3% / itraconazole 5% / urea 20% cream
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72934-2044
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CICLOPIROX OLAMINE (UNII: 50MD4SB4AP) (CICLOPIROX - UNII:19W019ZDRJ) CICLOPIROX3 g  in 100 g
ITRACONAZOLE (UNII: 304NUG5GF4) (ITRACONAZOLE - UNII:304NUG5GF4) ITRACONAZOLE5 g  in 100 g
UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA20 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72934-2044-230 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/20/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/20/2019
Labeler - Sincerus Florida, LLC (080105003)
Establishment
NameAddressID/FEIBusiness Operations
Sincerus Florida, LLC080105003manufacture(72934-2044)

Revised: 5/2019
Document Id: 8956c20e-0269-317e-e053-2a95a90a486f
Set id: 8956c20e-0268-317e-e053-2a95a90a486f
Version: 1
Effective Time: 20190520
 
Sincerus Florida, LLC