Label: LIDOCAINE AND PRILOCAINE cream

  • NDC Code(s): 70771-1872-2, 70771-1872-5, 70771-1872-8
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 30, 2024

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1872-5

    Lidocaine and Prilocaine Cream USP, 2.5%/2.5%

    5 grams

    Rx

    tube-label
  • INGREDIENTS AND APPEARANCE
    LIDOCAINE AND PRILOCAINE 
    lidocaine and prilocaine cream
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1872
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE25 mg  in 1 g
    PRILOCAINE (UNII: 046O35D44R) (PRILOCAINE - UNII:046O35D44R) PRILOCAINE25 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITE (off-white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1872-85 in 1 CARTON01/01/2025
    1NDC:70771-1872-55 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:70771-1872-21 in 1 CARTON01/01/2025
    230 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21912001/01/2025
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (650199482)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited650650802ANALYSIS(70771-1872) , MANUFACTURE(70771-1872)