HYDROCORTISONE 2.5% / LEVOCETIRIZINE DIHYDROCHLORIDE 2%- hydrocortisone 2.5% / levocetirizine dihydrochloride 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.

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HYDROCORTISONE 2.5% / LEVOCETIRIZINE DIHYDROCHLORIDE 2%

Directions for use

df

Sincerus Florida, LLC. Adverse reactions

ss

Active, inactive

dd

NDC 72934- 2113-2 HYDROCORTISONE 2.5% / LEVOCETIRIZINE DIHYDROCHLORIDE 2%. Gel 30gm.

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HYDROCORTISONE 2.5% / LEVOCETIRIZINE DIHYDROCHLORIDE 2% 
hydrocortisone 2.5% / levocetirizine dihydrochloride 2% cream
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72934-2113
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE2.5 g  in 100 g
LEVOCETIRIZINE DIHYDROCHLORIDE (UNII: SOD6A38AGA) (LEVOCETIRIZINE - UNII:6U5EA9RT2O) LEVOCETIRIZINE DIHYDROCHLORIDE2 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72934-2113-230 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/15/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/15/2019
Labeler - Sincerus Florida, LLC (080105003)
Establishment
NameAddressID/FEIBusiness Operations
Sincerus Florida, LLC080105003manufacture(72934-2113)

Revised: 5/2019
Document Id: 88df0f6a-620d-6a38-e053-2a95a90a3a8d
Set id: 88df0f6a-620c-6a38-e053-2a95a90a3a8d
Version: 1
Effective Time: 20190514
 
Sincerus Florida, LLC