FLUOCINONIDE - fluocinonide solution 
Zydus Lifesciences Limited

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Fluocinonide topical solution USP, 0.05%

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1375-8

Fluocinonide topical solution USP, 0.05%

Rx only

20 mL

Fluocinonide topical solution USP, 0.5%
image
Fluocinonide topical solution USP, 0.05%
FLUOCINONIDE 
fluocinonide solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1375
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FLUOCINONIDE (UNII: 2W4A77YPAN) (FLUOCINONIDE - UNII:2W4A77YPAN) FLUOCINONIDE0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1375-820 mL in 1 BOTTLE; Type 0: Not a Combination Product11/01/2018
2NDC:70771-1375-360 mL in 1 BOTTLE; Type 0: Not a Combination Product11/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20894811/01/2018
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (650650802)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited650650802ANALYSIS(70771-1375) , MANUFACTURE(70771-1375)

Revised: 8/2022
Document Id: 5880cc88-7ad8-49aa-913b-e9546732c7fa
Set id: 72b19e31-49e8-4bd7-8205-997f0c6a43f1
Version: 4
Effective Time: 20220826
 
Zydus Lifesciences Limited