Label: MARSHALL TOOTHACHE DROPS (eugenol 85%- clove oil 2% v/v solution/ drops

  • 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 May 18, 2021

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

  • ACTIVE INGREDIENT

    Drug Facts

    Active Ingredient: Eugenol 85% (Clove Oil 2% v/v)

  • PURPOSE

    Purpose: Surface Anaesthetic

  • INDICATIONS & USAGE

    Uses: Acts as a surface anaesthetic temporarily relieving a toothache due to a cavity, until a dentist can be seen.

  • WARNINGS

    Warnings:

    For external use only.

    Allergy alert: do not use if you are allergic to 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 48 hours.
    • Do NOT use more than the recommended dose.

    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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions for Use:
    Adults and Children over 12 years:

    • Rinse tooth with water to remove any food particles from the cavity
    • Apply 1-2 drops to a piece of cotton wool
    • Swab affected area with the cotton wool or plug into affected cavity
    • Leave in tooth cavity for 1 minute without touching surrounding tissues, then remove and discard.
    • Discontinue use if irritation occurs. Avoid contact with cheek, gums, palate and lips
    • Supervise children using this product

    Use up to 4 times daily or as directed by a dentist or doctor.

  • OTHER SAFETY INFORMATION

    Other information. Do not purchase if package has been opened.

    Store at 46 – 90 F. (8 – 32 oC). Cap tightly to avoid evaporation.

  • INACTIVE INGREDIENT

    Inactive ingredients: Ethyl alcohol, Purified water, Carmoisine red dye

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Marshall Toothache Drops - 10 ml (0.33 fl.oz) - NDC 74094-002-01 - Carton

    Marshall Toothache Drops - 10 ml (0.33 fl.oz) - NDC 74094-002-01 - Carton

    Marshall Toothache Drops - 10 ml (0.33 fl.oz) - NDC 74094-002-01 - Container

    Marshall Toothache Drops - 10 ml (0.33 fl.oz) - NDC 74094-002-01 - Container

  • INGREDIENTS AND APPEARANCE
    MARSHALL TOOTHACHE DROPS 
    eugenol 85% (clove oil 2% v/v) solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74094-002
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EUGENOL (UNII: 3T8H1794QW) (EUGENOL - UNII:3T8H1794QW) EUGENOL17 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M) 529 mg  in 1 mL
    WATER (UNII: 059QF0KO0R) 310 mg  in 1 mL
    CARMOISINE (UNII: DR4641L47F) 0.1 mg  in 1 mL
    Product Characteristics
    Colorred (Clear red liquid with odour of clove oil) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74094-002-011 in 1 CARTON05/17/2021
    110 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 finalpart35605/17/2021
    Labeler - Yashvire LLC (117396744)
    Registrant - MARSHALLS TRADITIONAL HEALTHCARE CC (637662219)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARSHALLS TRADITIONAL HEALTHCARE CC637662219manufacture(74094-002) , pack(74094-002) , label(74094-002)