Label: ORCA COMPLETE MENTHOL PAIN RELIEVER- menthol liquid

  • NDC Code(s): 82939-000-01, 82939-000-02
  • Packager: ORCA Products, LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 8, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Drug Facts

  • Active ingredient

    Menthol 2%

  • Purpose

    oral pain reliever

  • Use

    • for the temporary relief of pain due to minor irritation or injury of the mouth and gums
  • Warnings

    Do not use

    • this product for more than 7 days unless directed by a dentist or doctor.

    When using this product

    • do not exceed recommended dosage.

    Stop use and ask a doctor if

    • sore mouth symptoms do not improve in 7 days 
    • irritation, pain, or redness persists or worsens 
    • swelling, rash, or fever develops

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact Poison Control Center right away.

  • Directions

    • Adults and children 12 years of age and older: Place 8-10 drops onto ORCA Foam or similar resorbable gelatin sponge or gauze strip in a sterile fashion and apply to areas of discomfort in oral region. Guaze strip requires removal. Orca Foam soaked sponge will resorb and does not require removal.
    • Children under 12 years of age should be supervised in use of this product.
    • Children under 12 years of age: Consult a dentist or doctor.
  • Other information

    • Do not use if tamperproof seal is not intact at time of first use.
  • Inactive ingredients

    Clove oil, glycerin, guaiacol, oregano oil, peppermint oil.

  • Questions?

    1-970-401-1138 MON-FRI 8 AM to 3 PM (CST)

  • Package Labeling: 82939-000-02

    LabelPrint Label

  • INGREDIENTS AND APPEARANCE
    ORCA COMPLETE MENTHOL PAIN RELIEVER 
    menthol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82939-000
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CLOVE OIL (UNII: 578389D6D0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GUAIACOL (UNII: 6JKA7MAH9C)  
    OREGANO LEAF OIL (UNII: 7D0CGR40U1)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82939-000-011 in 1 BOX09/15/202208/31/2025
    110 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    2NDC:82939-000-021 in 1 BOX09/15/2023
    213 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02209/15/2022
    Labeler - ORCA Products, LLC (117716283)
    Registrant - ORCA Products, LLC (117716283)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!