CLOBETASOL PROPIONATE - clobetasol propionate lotion 
Zydus Lifesciences Limited

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CLOBETASOL PROPIONATE lotion, 0.05%

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1498-7

Clobetasol Propionate Lotion, 0.05%

Rx only

118 mL

Front label
back label
carton
CLOBETASOL PROPIONATE 
clobetasol propionate lotion
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1498
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOBETASOL PROPIONATE (UNII: 779619577M) (CLOBETASOL - UNII:ADN79D536H) CLOBETASOL PROPIONATE0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
MINERAL OIL (UNII: T5L8T28FGP)  
PEG-6 ISOSTEARATE (UNII: 0E2639OTJY)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1498-71 in 1 CARTON04/30/2020
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:70771-1498-61 in 1 CARTON04/30/2020
259 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20524904/30/2020
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited650650802ANALYSIS(70771-1498) , MANUFACTURE(70771-1498)

Revised: 11/2022
Document Id: c1298c3a-cf72-42be-8748-ad520666e589
Set id: d01b8f72-c2d2-49d8-87d7-3d60f11a7bbb
Version: 3
Effective Time: 20221105
 
Zydus Lifesciences Limited