Label: DENTEK INSTANT PAIN RELIEF MAXIMUM STRENGTH- benzocaine liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 5, 2023

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  • Active ingredient

    Benzocaine 20%

  • Purpose

    Oral Pain Reliever

  • Uses

    for the temporary relief of pain due to:

    • toothaches
    • canker sore
    • cold sores
    • sore gums
  • Warnings

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

    When using this product

    • avoid contact with the eyes
    • do not exceed recommended dosage
    • do not use for more than 7 days unless than 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 right away.

  • Directions

    dip applicator into liquid

    Adults and children 2 years of age and older: Apply a small amount of product to the affected area. Use up to 4 times daily or as directed by a dentist or doctor.

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

    Children under 2 years of age: Ask a dentist or doctor.

  • Other information

    • do not use if safety seal on carton is broken
    • this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted
    • do not use continuously
  • Inactive ingredients

    Carbowax 400, Peppermint Oil, Spearmint Oil, Sucralose

  • Questions or comments?

    Call us 800-4DENTEK (433-6835) M-F 8am - 5pm EST or email us at info@DenTek.com

  • DenTek Instant Pain Relief Inner Vial Label

    Entire Label

  • INGREDIENTS AND APPEARANCE
    DENTEK INSTANT PAIN RELIEF  MAXIMUM STRENGTH
    benzocaine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83062-410(NDC:60630-077)
    Route of AdministrationDENTAL
    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
    SUCRALOSE (UNII: 96K6UQ3ZD4) 10 mg  in 1 mL
    SPEARMINT OIL (UNII: C3M81465G5) 3.3 mg  in 1 mL
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) 784.5 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:83062-410-041 in 1 CARTON10/10/2022
    1NDC:83062-410-033.5 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 DrugM02210/10/2022
    Labeler - IIMED MEDICAL MEXICANA S. DE R.L. DE C.V (812894376)
    Establishment
    NameAddressID/FEIBusiness Operations
    IIMED MEDICAL MEXICANA S. DE R.L. DE C.V812894376relabel(83062-410) , repack(83062-410)
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