Label: COMFORTCAINE TOPICAL ANESTHETIC- benzocaine gel 

  • Label RSS
  • NDC Code(s): 55346-1404-1
  • Packager: Dental Technologies, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/12

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

  • Active Ingredient

    Benzocaine 20%

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  • Purpose

    Oral Anesthetic

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  • Uses

    For the temporary relief of occasional pain and minor irritation associated with:

    • canker sores
    • ulcers
    • minor dental procedures
    • needle punctures
    • minor injury of the mouth and gums
    • minor irritation of the mouth and gums caused by dentures or orthodontic appliances
    • sore mouth and throat
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  • Warnings

    Do not use if you have a history of allergy to any "caine" anesthetics, such as benzocaine, butacaine, procaine, or tetracaine.

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  • Stop use and ask a doctor if

    • Sore mouth symptoms do not improve in 7 days or if irritation, pain, or redness persists or worsens.
    • Sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, nausea, rash, swelling, or vomiting.
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  • When using this product

    • Avoid contact with eyes
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  • Keep out of reach of children.

    If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

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  • Directions

    Do not exceed recommended dosage. Adults and children 2 years of age or older

    Apply to the affected area. Allow to remain in place at least 1 minute and then spit out. Use up to 3 times daily or as directed by a dentist or doctor.

    Children under 12 years of age Should be supervised in the use of the product.

    Children under 2 years of age Consult a dentist or doctor

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  • Other information:

    Do not use if imprinted seal under cap is broken or missing.

    Store at 59° to 86° F (15° to 30° C)

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  • Inactive ingredients:

    Flavoring, polyethylene glycol base, sodium saccharin.

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  • Questions or Comments?

    Call 1-800-323-4532 or 1/847-679-3400

    M-F: 8:00AM to 5:00PM

    Central Time

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  • SPL UNCLASSIFIED SECTION

    Bosworth® Company

    7227 N. Hamlin Avenue

    Skokie, IL 60076

    800.323.4352

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  • Principal Display Panel

    Bosworth® ComfortCaineâ„¢

    Topical Anesthetic

    NDC 55346-1404-1

    Ref 16603

    1 oz.(30g.)

    Cherry

    0510PR725

    image of carton

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  • INGREDIENTS AND APPEARANCE
    COMFORTCAINE  TOPICAL ANESTHETIC
    benzocaine gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55346-1404
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Benzocaine (BENZOCAINE) Benzocaine 200 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Polyethylene Glycol 400  
    Polyethylene Glycol 3350  
    SACCHARIN SODIUM  
    SILICON DIOXIDE  
    FD&C RED NO. 3  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor CHERRY (Cherry) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55346-1404-1 30 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 01/01/1997
    Labeler - Dental Technologies, Inc. (148312838)
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