Label: DENTEK INSTANT PAIN RELIEF MAXIMUM STRENGTH- benzocaine liquid

  • NDC Code(s): 60630-077-03, 60630-077-04
  • Packager: DenTek Oral Care, Inc.
  • 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 October 18, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Benzocaine 20%

  • Purpose

    Oral pain reliever

  • Use

    for the temporary relief of pain due to:

    • toothaches
    • canker sores
    • cold sores
    • sore gums
  • 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 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 this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other “caine” anesthetics.

    Do not use

    • for teething
    • in children under 2 years of age

    When using this product

    • avoid contact with the eyes
    • do not exceed recommended dosage
    • do not use for more than 7 days unless directed by a doctor/dentist

    Stop use and ask a dentist or doctor if 

    • swelling, rash or fever develops
    • irritation, pain or redness persists or worsens
    • symptoms do not improve in 7 days

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    dip applicator into liquid

    Adults and children 2 years and olderApply a small amount of product to the affected area. Use up to 4 times daily or as directed by a dentist or doctor.
    Children between 2 and 12 years Should be supervised in the use of this product.
    Children under 2 years Do not use.

         

  • Other information

    • for toothaches, use only as a temporary remedy until a dentist can be seen
    • store at 20-25⁰C (68-77⁰F).
  • Inactive ingredients

    Peppermint Oil, Polyethylene Glycol 400, Spearmint Oil, Sucralose 

  • PRINCIPAL DISPLAY PANEL

    DenTek™ 

    INSTANT PAIN RELIEF

    Benzocaine 20% / ORAL ANESTHETIC

    1 BOTTLE OF BENZOCAINE 0.118 fl oz (3.5 mL), 1 CASE, 50 APPLICATORS, 1 HANDLE

    PRINCIPAL DISPLAY PANEL DenTek™ INSTANT PAIN RELIEF Benzocaine 20% / ORAL ANESTHETIC 1 BOTTLE OF BENZOCAINE 0.118 fl oz (3.5 mL), 1 CASE, 50 APPLICATORS, 1 HANDLE  PRINCIPAL DISPLAY PANEL DenTek™ INSTANT PAIN RELIEF Benzocaine 20% / ORAL ANESTHETIC 1 BOTTLE OF BENZOCAINE 0.118 fl oz (3.5 mL), 1 CASE, 50 APPLICATORS, 1 HANDLE

  • INGREDIENTS AND APPEARANCE
    DENTEK INSTANT PAIN RELIEF  MAXIMUM STRENGTH
    benzocaine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60630-077
    Route of AdministrationDENTAL, TOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PEPPERMINT OIL (UNII: AV092KU4JH) 2.2 mg  in 1 mL
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) 784.5 mg  in 1 mL
    SPEARMINT OIL (UNII: C3M81465G5) 3.3 mg  in 1 mL
    SUCRALOSE (UNII: 96K6UQ3ZD4) 10 mg  in 1 mL
    Product Characteristics
    Coloryellow (colorless to light yellow liquid) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60630-077-041 in 1 CARTON07/31/2015
    1NDC:60630-077-033.5 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35607/31/2015
    Labeler - DenTek Oral Care, Inc. (153818646)
    Registrant - DenTek Oral Care, Inc. (153818646)
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