Label: IVERMECTIN cream

  • NDC Code(s): 70771-1728-2, 70771-1728-3, 70771-1728-4
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated June 7, 2023

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  • SPL UNCLASSIFIED

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Ivermectin Cream, 1%

    45 gm

    NDC 70771-1728-4

    Rx only

    container label
    carton label
  • INGREDIENTS AND APPEARANCE
    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)