Label: EUGENOL- 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 December 17, 2014

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

  • Active ingredients:

    Eugenol 85%

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  • Purpose

    Toothache Relief Agent

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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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  • Uses:

    For the temporary relief of throbbing, persistent toothache due to 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).
    When using this product:
    • use only in teeth with persistent, throbbing pain
    • avoid touching tissues other than tooth cavity
    • DO NOT SWALLOW to avoid irritation
    • do not use for more than 7 days
    • do not exceed recommended dosage
    Stop use and ask a dentist or doctor if irritation persists, inflammation develops, or if fever and infection develop.

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  • Directions

    Adults and children 12 years of age and older Rinse the tooth with water to remove any food particles from the cavity. Moisten a cotton pellet with 1 to 2 drops of Eugenol and 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.
    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.

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  • Inactive ingredient

    sesame oil

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  • QUESTIONS

    Questions or comments? 1-888-811-6188

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  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015
    100% SATISFACTION GUARANTEED
    walgreens.com ©2012 Walgreen Co.
    MADE IN U.S.A
    0712-250608A ORG1112-GF

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  • Packaging
  • INGREDIENTS AND APPEARANCE
    EUGENOL 
    eugenol liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:61291-011
    Route of Administration ORAL
    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)  
    Product Characteristics
    Color brown Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61291-011-04 3.7 mL in 1 VIAL, GLASS
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 01/30/2015
    Labeler - Polysciences, Inc (014249635)
    Establishment
    Name Address ID/FEI Business Operations
    Polysciences, Inc 014249635 manufacture(61291-011)
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