Label: DENTEK EUGENOL- eugenol liquid


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 10, 2022

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  • Active ingredient

    Eugenol 85%

  • Purpose

    Toothache Relief Agent

  • Uses

    For the temporary relief of throbbing, persisitent toothache due to a cavity. Visit Dentist within 48 hours of use.

  • Warnings

    Allergy alert: do not use if you are allergic to eugenol (clove oil).

    When using this product

    • use only in teeth with persistent throbbing pain
    • avoid touching tissuers other than tooth cavity
    • DO NOT SWALLOW to avoid irritation
    • avoid contact with eyes.

    Do not use

    • for more than 7 days
    • more than the recommended dosage.

    Stop use and ask a dentist or doctor if

    • irritation persists
    • inflammation develops
    • if fever and infection develop.

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Directions Adults and children 12 year of age and older: Rinse the tooth with water to remove any food particles from the cavity. Moisten a cotton swab with Eugenol and place in the cavity for approximately 1 minute. Avoid touching tissue other than the tooth cavity. Apply the dose not more than four times daily or as directed by dentist or physician.

    Adults and children 12 years and older use up to 4 times daily or as directed by a dentist or doctor.

    Children under 12 years ask a dentist or doctor.

  • Inactive ingredient

    sesame oil

  • Other information

    • Do not purchase if package has been opened
    • Store at 68-77 o F
    • Cap tightly to avoid evaporation.
  • DenTek Dental First Aid Kit

    Entire label

    eugenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83062-400(NDC:60630-566)
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EUGENOL (UNII: 3T8H1794QW) (EUGENOL - UNII:3T8H1794QW) EUGENOL850 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SESAME OIL (UNII: QX10HYY4QV) 150 mg  in 1 mL
    Product Characteristics
    Coloryellow (clear to pale yellow liquid with odor) Score    
    FlavorImprint Code
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83062-400-211 in 1 KIT10/10/2022
    1NDC:83062-400-203.5 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 finalpart35610/10/2022
    Labeler - IIMED MEDICAL MEXICANA S. DE R.L. DE C.V. (812894376)
    NameAddressID/FEIBusiness Operations
    IIMED MEDICAL MEXICANA S. DE R.L. DE C.V.812894376relabel(83062-400) , repack(83062-400)