CLOBETASOL PROPIONATE - clobetasol propionate cream 
Zydus Lifesciences Limited

----------

Clobetasol Propionate Cream USP, 0.05%

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1442-1

Clobetasol Propionate Cream USP, 0.05%

Rx only

15 g

Clobetasol Propionate Cream
Clobetasol Propionate Cream
CLOBETASOL PROPIONATE 
clobetasol propionate cream
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1442
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOBETASOL PROPIONATE (UNII: 779619577M) (CLOBETASOL - UNII:ADN79D536H) CLOBETASOL PROPIONATE0.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
LANOLIN OIL (UNII: OVV5IIJ58F)  
PETROLATUM (UNII: 4T6H12BN9U)  
WATER (UNII: 059QF0KO0R)  
GLYCOL STEARATE (UNII: 0324G66D0E)  
PEG-8 STEARATE (UNII: 2P9L47VI5E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1442-11 in 1 CARTON01/09/2019
115 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:70771-1442-21 in 1 CARTON01/09/2019
230 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:70771-1442-41 in 1 CARTON01/09/2019
345 g in 1 TUBE; Type 0: Not a Combination Product
4NDC:70771-1442-31 in 1 CARTON01/09/2019
460 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21107401/09/2019
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (650650802)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited650650802ANALYSIS(70771-1442) , MANUFACTURE(70771-1442)

Revised: 10/2022
Document Id: 5716599f-59a6-4553-97aa-98f944e05e38
Set id: 7a277523-2b92-499f-be58-c410adda4fef
Version: 4
Effective Time: 20221013
 
Zydus Lifesciences Limited