Label: WALGREENS NATURAL EUGENOL/TOOTHACHE MEDICATION WITH COTTON PELLETS AND TWEEZERS- eugenol liquid

  • NDC Code(s): 60630-608-01, 60630-608-02
  • Packager: DenTek Oral Care, Inc.
  • 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 2, 2015

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  • Outer package card labeling

    Labeling for complete kit

  • 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 this product:

    . use only in teeth with pesistent, 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.

  • 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 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.

    Children under 12 years ask a dentist or doctor.

  • INACTIVE INGREDIENT

    Inactive Ingredient: sesame oil

  • QUESTIONS

    Questions or comments? 1-888-811-6188

  • INGREDIENTS AND APPEARANCE
    WALGREENS NATURAL EUGENOL/TOOTHACHE MEDICATION  WITH COTTON PELLETS AND TWEEZERS
    eugenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60630-608
    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 (pale yellow liquid, with odor of cloves) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60630-608-021 in 1 PACKAGE07/01/2015
    1NDC:60630-608-013.7 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)