METRONIDAZOLE- metronidazole cream 
Zydus Lifesciences Limited

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Metronidazole Topical Cream, 0.75%

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1834-4

Metronidazole Topical Cream, 0.75%

Rx only

45 g

tube label
carton label
METRONIDAZOLE 
metronidazole cream
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1834
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METRONIDAZOLE (UNII: 140QMO216E) (METRONIDAZOLE - UNII:140QMO216E) METRONIDAZOLE7.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
LACTIC ACID (UNII: 33X04XA5AT)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorWHITE (off-white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1834-41 in 1 CARTON05/31/2023
145 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21712805/31/2023
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited650650802ANALYSIS(70771-1834) , MANUFACTURE(70771-1834)

Revised: 5/2023
Document Id: bac9d2c8-3d87-4ec8-aa22-760d3c66440b
Set id: 728ebe6d-7a20-481d-845a-ceffa450179f
Version: 1
Effective Time: 20230505
 
Zydus Lifesciences Limited