Label: EUGENOL TOOTHACHE MEDICATION- eugenol liquid

  • 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 August 26, 2016

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

  • ACTIVE INGREDIENT

    Active Ingredient Eugenol 85%

  • PURPOSE

    Purpose Toothache Relief Agent

  • INDICATIONS & USAGE

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

  • WARNINGS

    Warnings

    For external use only. 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 . 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 dose

  • STOP USE

    Stop use and ask a dentist or doctor if. irritation persists . inflammation develops . 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 2 to 12 years of age and older: Rinse tooth with water to remove any food particles from the cavity. Moisten a cotton pellet with 1 or 2 drops of medication and using the tweezer, place in the cavity for approximately 1 minute. Avoid touching tissues other than the tooth cavity . Apply the dose not more than four times daily or as directed by a dentist or physician.

    Children 2 to 12 years of age: should be supervised in the use of this product.

    Children under 2 years of age: use only under the advice of a dentist or physician.

  • OTHER SAFETY INFORMATION

    Other information. Do not purchase if package has been opened. . Store at 46 - 90 o F. . Cap tightly to avoid evaporation. . toothaches and open cavities indicate serious problems which need prompt attention by a dentist.

  • INACTIVE INGREDIENT

    Inactive ingredient sesame oil

  • PRINCIPAL DISPLAY PANEL

    kit package label

  • INGREDIENTS AND APPEARANCE
    EUGENOL TOOTHACHE MEDICATION 
    eugenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67659-415(NDC:60630-686)
    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 (colorless to pale yellow liquid, with odor of cloves) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67659-415-211 in 1 KIT07/01/2015
    1NDC:67659-415-233.7 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 - Team Technologies, Inc (192339703)
    Registrant - Team Technologies, Inc (192339703)
    Establishment
    NameAddressID/FEIBusiness Operations
    Team Technologies, Inc079527756repack(67659-415) , relabel(67659-415)