Label: LIDOCAINE HYDROCHLORIDE VISCOUS- lidocaine hydrochloride gel

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated July 6, 2015

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  • PRINCIPAL DISPLAY PANEL

    Lidocaine Label 20mL cup

    Lidocaine Label_pg1Lidocaine Label_pg2

  • DOSAGE & ADMINISTRATION

    DELIVERS 20 ML

  • INGREDIENTS AND APPEARANCE
    LIDOCAINE HYDROCHLORIDE  VISCOUS
    lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:69938-101
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN (UNII: FST467XS7D)  
    ORANGE (UNII: 5EVU04N5QU)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69938-101-1120 mL in 1 CUP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/06/2015
    Labeler - TRUE FIT RX LLC (079868455)
    Registrant - TRUE FIT RX LLC (079868455)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hi-Tech Pharmacal - an Akorn Company869019794manufacture(69938-101)