CETACAINE ANESTHETIC- benzocaine, butamben, and tetracaine hydrochloride aerosol, spray

Cetacaine Anesthetic by

Drug Labeling and Warnings

Cetacaine Anesthetic by is a Prescription medication manufactured, distributed, or labeled by Cetylite Industries, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • SPL UNCLASSIFIED SECTION

    Made in USA

    Cetylite Industries, Inc.
    Pennsauken, NJ 08110

    Rev. 10 /18

    www.cetylite.com

  • PRINCIPAL DISPLAY PANEL - 20 g Bottle Box

    NDC: 10223-0201-3
    Item No. 0220

    Cetacaine®

    Topical Anesthetic
    SPRAY

    Control Pain
    Control Gagging
    Effective Only on
    Mucous Membrane

    Rx only

    Exclusive Spray
    Cannula Provides
    Complete Control
    (One Cannula Included)

    (Benzocaine 14.0%,
    Butamben 2.0%, Tetracaine
    Hydrochloride 2.0%)

    CETYLITE®
    Cetylite Industries, Inc.
    Pennsauken, NJ 08110-3293
    www.cetylite.com

    PRINCIPAL DISPLAY PANEL - 20 g Bottle Box
  • INGREDIENTS AND APPEARANCE
    CETACAINE ANESTHETIC 
    benzocaine, butamben, and tetracaine hydrochloride aerosol, spray
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 10223-0201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine0.028 g  in 0.2 g
    Butamben (UNII: EFW857872Q) (Butamben - UNII:EFW857872Q) Butamben0.004 g  in 0.2 g
    Tetracaine Hydrochloride (UNII: 5NF5D4OPCI) (Tetracaine - UNII:0619F35CGV) Tetracaine Hydrochloride0.004 g  in 0.2 g
    Inactive Ingredients
    Ingredient NameStrength
    Dipropylene glycol (UNII: E107L85C40)  
    Saccharin (UNII: FST467XS7D)  
    Benzalkonium chloride (UNII: F5UM2KM3W7)  
    Mecetronium bromide (UNII: 7ZNQ7FIO9K)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBANANAImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 10223-0201-11 in 1 BOX01/01/195801/31/2018
    156 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    2NDC: 10223-0201-31 in 1 BOX01/01/2016
    220 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    3NDC: 10223-0201-41 in 1 BOX11/01/2017
    35 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER01/01/1958
    Labeler - Cetylite Industries, Inc. (001283704)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cetylite Industries, Inc.001283704MANUFACTURE(10223-0201) , ANALYSIS(10223-0201) , LABEL(10223-0201) , PACK(10223-0201)

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