Label: NYSTATIN AND TRIAMCINOLONE ACETONIDE ointment

  • NDC Code(s): 70771-1447-1, 70771-1447-2, 70771-1447-3
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 28, 2020

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1447-1

    Nystatin and Triamcinolone Acetonide Ointment, 15 gm

    Rx only

    Nystatin and Triamcinolone Acetonide Ointment
  • INGREDIENTS AND APPEARANCE
    NYSTATIN AND TRIAMCINOLONE ACETONIDE 
    nystatin and triamcinolone acetonide ointment
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1447
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NYSTATIN (UNII: BDF1O1C72E) (NYSTATIN - UNII:BDF1O1C72E) NYSTATIN100000 [USP'U]  in 1 g
    TRIAMCINOLONE ACETONIDE (UNII: F446C597KA) (TRIAMCINOLONE ACETONIDE - UNII:F446C597KA) TRIAMCINOLONE ACETONIDE1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Product Characteristics
    ColorYELLOW (YELLOW) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1447-11 in 1 CARTON11/20/2018
    115 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:70771-1447-21 in 1 CARTON11/20/2018
    230 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:70771-1447-31 in 1 CARTON11/20/2018
    360 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20776411/20/2018
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (650650802)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited650650802ANALYSIS(70771-1447) , MANUFACTURE(70771-1447)