Label: GELATO TOPICAL ANESTHETIC- benzocaine gel

  • NDC Code(s): 68400-351-30
  • Packager: Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 7, 2023

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

  • Active Ingredients

    Benzocaine 200mg (in each g)

  • Purpose:

    Oral Anesthetic

  • Use

    For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.

  • 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.
    Do not use
    • for more than 7 days unless directed by a physician. If sore mouth symptoms do not improve in 7 days; irritation, pain or redness persists or worsens; or if swelling, rash or fever develops, see your physician promptly.
    • for teething
    • in children under 2 years of age
    When using this product Avoid contact with eyes. If contact occurs, flush with water.
    Do not exceed recommended dosage. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.
    If pregnant or breast feeding, ask a physician before use.

  • Directions

    • Apply only amount needed to the oral mucosa to prevent or relieve pain.
    • children under 2 years of age: do not use
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Other Information:

    Store at 59°-86°F (15°-30°C). Protect from freezing.

  • Inactive Ingredients:

    Flavoring, PEG 3350, PEG 400, sodium saccharin. May contain blue #1, green #3, green #5, red #3, red #28, red #40, yellow#5 (tartrazine), yellow #6, as a color additive.

  • Questions or comments?

    1-800-333-3131 or

    keystoneindustries.com

  • PRINCIPAL DISPLAY PANEL

    LB.Gelato_Topical Wrap_Approved.jpg

  • INGREDIENTS AND APPEARANCE
    GELATO TOPICAL ANESTHETIC 
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68400-351
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    Product Characteristics
    ColorpinkScore    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68400-351-3030 g in 1 JAR; Type 0: Not a Combination Product06/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02207/01/2013
    Labeler - Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc (014769301)
    Establishment
    NameAddressID/FEIBusiness Operations
    Keystone Industries014769301manufacture(68400-351) , label(68400-351)