Label: GELATO TOPICAL ANESTHETIC- benzocaine spray, metered

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 21, 2022

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  • Active Ingredient

    Benzocaine 20%

  • Purpose

    Oral Anesthetic

  • Uses

    • For the temporary relief of occasional minor irritation and pain associated with canker sores and minor dental procedures.
    • For Professional Use Only.
  • Warnings

    Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in the blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

    • pale, gray or blue colored skin (cyanosis)
    • headache
    • rapid heart rate
    • shortness of breath
    • dizziness or lightheadedness
    • fatigue or lack of energy

    Allergy Alert: Do not use on patients with a history of allergies to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

    Flammable. Do not use near fire or flame. Avoid smoking during use.

    Do not use

    • for teething
    • in children under 2 years of age
  • Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away. Avoid spraying in eyes.

  • Directions

    Apply only amount needed to the oral mucosa to prevent or relieve pain.

    • Children under 2 years of age: do not use
  • Other information

    Store at room temperature. Do not store above 120°F (49°C). Dispose of in a manner consistent with local regulations.

  • Inactive Ingredients

    Ethyl Alcohol, Flavor, Polyethylene Glycol, Sodium Saccharin, Hydrocarbon Propellant (Isobutane and propane).

  • Questions or comments?

    1-800-333-3131

  • PRINCIPAL DISPLAY PANEL

    BX.Gelato Topical Metered Spray.jpg

  • PRINCIPAL DISPLAY PANEL

    LB.Metered Spray_99088504.jpg

  • INGREDIENTS AND APPEARANCE
    GELATO TOPICAL ANESTHETIC 
    benzocaine spray, metered
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68400-323
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE11.4 g  in 57 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    ALCOHOL (UNII: 3K9958V90M)  
    ISOBUTANE (UNII: BXR49TP611)  
    PROPANE (UNII: T75W9911L6)  
    Product Characteristics
    Colorwhite (Clear) Score    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68400-323-3557 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35607/29/2013
    Labeler - Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc (014769301)
    Establishment
    NameAddressID/FEIBusiness Operations
    Keystone Industries014769301manufacture(68400-323) , label(68400-323)
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