Label: DENTEK EUGENOL- eugenol liquid

  • Category: HUMAN OTC DRUG LABEL

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 December 28, 2015

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  • ACTIVE INGREDIENT

    Active Ingredient Eugenol 85%

  • PURPOSE

    Purpose Toothache Relief Agent

  • INDICATIONS & USAGE

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

  • WARNINGS

    Warnings

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

  • WHEN USING

    When using this product:. use only in teeth with persistent, throbbing pain . avoid touching tissuers othere than tooth cavity . DO NOT

    SWALLOW to avoid irritation . avoid contact with eyes.

  • DO NOT USE

    Do not use: . for more than 7 days . more than the recommended dosage.

  • STOP USE

    Stop use and ask a dentist or doctor if: . irritation persists . inflammation develops . if fever and infection develop.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    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

    Inactive ingredient: sesame oil

  • OTHER SAFETY INFORMATION

    Other information Do not purchase if package has been opened. Store at 68-77 o F. Cap tightly to avoid evaporation.

  • Outer Retail Package Label - DenTek Dental First Aid Kit

    front and back of card

  • INGREDIENTS AND APPEARANCE
    DENTEK EUGENOL 
    eugenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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 of cloves) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60630-566-021 in 1 KIT07/01/2015
    1NDC:60630-566-013.7 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 finalpart35607/01/2015
    Labeler - DenTek Oral Care, Inc. (153818646)
    Registrant - DenTek Oral Care, Inc. (153818646)
    Establishment
    NameAddressID/FEIBusiness Operations
    Polysciences, Inc.014249635manufacture(60630-566)
    Establishment
    NameAddressID/FEIBusiness Operations
    DenTek Oral Care, Inc.153818646label(60630-566)
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