Label: RED CROSS TOOTHACHE- eugenol liquid

  • NDC Code(s): 10742-0009-1
  • Packager: The Mentholatum Company
  • 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 January 13, 2020

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  • Active ingredient

    Eugenol 85%

  • Purpose

    Toothache relief agent

  • Uses

    temporarily relieves throbbing, persistent toothache due to a cavity until a dentist can be seen

  • 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. Contact with lips or mucous membranes can cause burning, swelling, or irritation.
    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

    See a dentist as soon as possible whether or not the pain is relieved. Toothaches and open cavities indicate serious problems that need prompt attention by a dentist.

  • Keep Out of Reach of Children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    rinse tooth with water to remove any food particles from the cavity
    using tweezers, immerse cotton pellet in medication
    to prevent dripping, squeeze gently between fingers to remove excess liquid
    place pellet in tooth cavity for one minutewithout touching surrounding tissues, then remove
    supervise children using this product

    adults and children 12 years and over: use up to 4 times daily or as directed by a dentist or doctor

    children under 12 years: ask a dentist or doctor

  • Inactive Ingredients

    sesame oil

  • Questions

    1-877-636-2677 MON-FRI 9 AM to 5 PM (EST)

  • Package/Label Principal Display Panel

    Red Cross Toothache
  • Principal Display Panel

    Drug Facts
  • INGREDIENTS AND APPEARANCE
    RED CROSS TOOTHACHE 
    eugenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-0009
    Route of AdministrationTOPICAL
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10742-0009-11 in 1 BLISTER PACK06/21/1983
    13.7 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35606/21/1983
    Labeler - The Mentholatum Company (002105757)
    Registrant - The Mentholatum Company (002105757)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Mentholatum Company002105757MANUFACTURE(10742-0009)