IVERMECTIN- ivermectin cream 
Zydus Lifesciences Limited

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Ivermectin Cream

SPL UNCLASSIFIED

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ivermectin Cream, 1%

45 gm

NDC 70771-1728-4

Rx only

container label
carton label
IVERMECTIN 
ivermectin cream
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1728
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IVERMECTIN (UNII: 8883YP2R6D) (IVERMECTIN - UNII:8883YP2R6D) IVERMECTIN10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorWHITE (white to pale yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1728-21 in 1 CARTON06/10/2023
130 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:70771-1728-41 in 1 CARTON06/10/2023
245 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:70771-1728-31 in 1 CARTON06/10/2023
360 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21521006/10/2023
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited650650802ANALYSIS(70771-1728) , MANUFACTURE(70771-1728)

Revised: 6/2023
Document Id: b32bd5aa-25fa-45a8-8efc-502e16d73735
Set id: 22e85f9a-0805-47f2-8709-aa6514511b04
Version: 3
Effective Time: 20230607
 
Zydus Lifesciences Limited