Label: ORCA PAIN RELIEVER PUTTY WITH MENTHOL- menthol paste

  • NDC Code(s): 82939-001-01, 82939-001-02
  • Packager: ORCA Products, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 10, 2023

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  • Drug Facts

  • Active ingredient

    Menthol 1.6%

  • 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: Allow product dissolve slowly in the mouth. May be repeated every 2 hours as needed or as directed by a dentist or doctor
    • Children under 12 years of age: Consult a dentist or doctor.
  • Other information

    • Do not use if outer package is broken, cut or torn.
  • Inactive ingredients

    Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Carthamus Tinctorius (Safflower) Seed Oil, Chamomilla Recutita (Matricaria) Flower Extract, Cinnamomum Zeylanicum Bark Oil, Elettaria Cardamomum Seed Oil, Eugenol, Glycerin, Glyceryl Caprylate, Glyceryl Undecylenate, Guaiacol, Maltodextrin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Xanthan Gum, Xylitol

  • Questions?

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

  • Package Labeling: 82939-001-01

    putty labelputty lid label

  • INGREDIENTS AND APPEARANCE
    ORCA PAIN RELIEVER PUTTY WITH MENTHOL 
    menthol paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82939-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM8.4 mg  in 0.525 g
    Inactive Ingredients
    Ingredient NameStrength
    CARDAMOM OIL (UNII: JM0KJ091HZ)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CINNAMON OIL (UNII: E5GY4I6YCZ)  
    CLOVE OIL (UNII: 578389D6D0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GUAIACOL (UNII: 6JKA7MAH9C)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    XYLITOL (UNII: VCQ006KQ1E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82939-001-011 in 1 PACKAGE09/15/202212/20/2024
    14.2 g in 1 JAR; Type 0: Not a Combination Product
    2NDC:82939-001-021 in 1 BLISTER PACK09/15/2022
    27 g in 1 JAR; 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)
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