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%

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  • PURPOSE

    Purpose Toothache Relief Agent

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  • INDICATIONS & USAGE

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

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  • WARNINGS

    Warnings

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

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  • WHEN USING

    When using this product:

    . use only in teeth with persistent throbbing pain . DO NOT SWALLOW to avoid irritation . avoid contact with eyes

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  • DO NOT USE

    Do not use. For more than 7 days . more than the recommended dose

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  • STOP USE

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

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  • 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.

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  • 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.

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  • 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.

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  • INACTIVE INGREDIENT

    Inactive ingredient sesame oil

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  • INGREDIENTS AND APPEARANCE
    EUGENOL TOOTHACHE MEDICATION 
    eugenol liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:67659-415(NDC:60630-686)
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    EUGENOL (UNII: 3T8H1794QW) (EUGENOL - UNII:3T8H1794QW) EUGENOL 850 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    SESAME OIL (UNII: QX10HYY4QV) 150 mg  in 1 mL
    Product Characteristics
    Color yellow (colorless to pale yellow liquid, with odor of cloves) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67659-415-21 1 in 1 KIT 07/01/2015
    1 NDC:67659-415-23 3.7 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 07/01/2015
    Labeler - Team Technologies, Inc (192339703)
    Registrant - Team Technologies, Inc (192339703)
    Establishment
    Name Address ID/FEI Business Operations
    Team Technologies, Inc 079527756 repack(67659-415) , relabel(67659-415)
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