Label: LIDOCAINE ointment

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 31, 2019

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 71589-001-30

    Rx only

    Lidocaine Ointment USP, 5%

    Laminate Tube with Child-Resistant Cap

    FOR TOPICAL USE ONLY. DO NOT USE IN THE EYES

    NET WT 30 g

    30g tube

    NDC 71589-001-35

    Rx only

    Lidocaine Ointment USP, 5%

    Laminate Tube with Child-Resistant Cap

    FOR TOPICAL USE ONLY. DO NOT USE IN THE EYES

    NET WT 35.44 g (1¼ Oz)

    35g tube

    NDC 71589-001-50

    Rx only

    Lidocaine Ointment USP, 5%

    Wide mouth Jar with Child-Resistant Cap

    FOR TOPICAL USE ONLY. DO NOT USE IN THE EYES

    NET WT 50 g (1¾ Oz)

    50g jar
  • INGREDIENTS AND APPEARANCE
    LIDOCAINE 
    lidocaine ointment
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:71589-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71589-001-301 in 1 CARTON11/30/2018
    130 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:71589-001-351 in 1 CARTON11/30/2018
    235.44 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:71589-001-5050 g in 1 JAR; Type 0: Not a Combination Product11/30/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21146911/30/2018
    Labeler - Aleor Dermaceuticals Limited (871411532)
    Registrant - Aleor Dermaceuticals Limited (871411532)
    Establishment
    NameAddressID/FEIBusiness Operations
    Encube Ethicals Pvt. Ltd.725076298MANUFACTURE(71589-001)
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