HYDROCORTISONE 2.5% / KETOCONAZOLE 2%- hydrocortisone 2.5% / ketoconazole 2% 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.

----------

HYDROCORTISONE 2.5% / KETOCONAZOLE 2%

Directions for use

s

Sincerus Florida, LLC. Adverse reactions

cc

Active, inactive

ss

NDC 72934- 2112-2 HYDROCORTISONE USP 2.5% / KETOCONAZOLE USP 2% . Cream 30gm.

c

HYDROCORTISONE 2.5% / KETOCONAZOLE 2% 
hydrocortisone 2.5% / ketoconazole 2% cream
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72934-2112
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE2.5 g  in 100 g
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE2 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72934-2112-230 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/17/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/17/2019
Labeler - Sincerus Florida, LLC (080105003)
Establishment
NameAddressID/FEIBusiness Operations
Sincerus FLorida, LLC080105003manufacture(72934-2112)

Revised: 5/2019
Document Id: 89026ad5-ed04-5058-e053-2a95a90ad2b0
Set id: 89026ad5-ed03-5058-e053-2a95a90ad2b0
Version: 1
Effective Time: 20190516
 
Sincerus Florida, LLC