Label: IODENT MAXIMUM STRENGTH ORAL ANALGESIC  - benzocaine gel 

  • Label RSS
  • 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 05/13

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

  • ACTIVE INGREDIENT

    Active ingredient                                                           Purpose

    Benzocaine 20%...............................................Oral pain reliever

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  • PURPOSE

    Uses temporarily relieves pain due to toothache, canker sores, cold sores, fever blisters, minor irritation of the mouth and gums caused by dentures or orthodontic appliances

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  • WARNINGS

    Warnings Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics

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  • DO NOT USE

    Do not use

    • more than directed
    • for more than 7 days unless directed by a doctor/dentist
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  • STOP USE

    Stop use and ask a doctor if

    • swelling, rash, or fever develops
    • irritation, pain, or redness persists or worsens
    • symptoms do not improve in 7 days
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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away

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  • INDICATIONS & USAGE

    Directions

    • remove cap and cut tip of tube on score mark
    • adults and children 2 years of age and older: apply a small amount of Oral Analgesic Gel to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by a doctor or dentist.
    • children under 12 years of age: should be supervised in the use of this product
    • children under 2 years of age: ask a doctor/dentist
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  • STORAGE AND HANDLING

    Other information

    • store at 15° to 25°C (59° to 77°F)
    • do not use if tube tip is cut prior to opening
    • This preparation is intended for use in cases of toothaches, only as a temporary expedient until a dentist can be consulted.
    • Do not use continuously
    • Lot No. and Exp Date: see box or see crimp of tube
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  • INACTIVE INGREDIENT

    Inactive ingredients flavor mint, glycerin, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium, sorbitol

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  • DOSAGE & ADMINISTRATION

    Distributed by:

    United Exchange Corp.

    17211 Valley View Ave.

    Cerritos, CA 90703 USA

    Made in Korea

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  • INGREDIENTS AND APPEARANCE
    IODENT MAXIMUM STRENGTH ORAL ANALGESIC  
    benzocaine gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:65923-010
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOCAINE (BENZOCAINE) BENZOCAINE 20 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    GLYCERIN  
    POLYETHYLENE GLYCOL 400  
    POLYETHYLENE GLYCOL 4000  
    SACCHARIN SODIUM  
    SORBITOL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65923-010-11 1 in 1 CARTON
    1 11.9 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 05/31/2013
    Labeler - United Exchange Corp (840130579)
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