Label: THERGY- thymol spray

  • 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 February 1, 2022

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  • ACTIVE INGREDIENT

    Drug Facts

    ​ ​Active Ingredients

    Thymol 0.05%

  • PURPOSE

    ​Purpose​​

    Oral Analgesic/Antimicrobial

  • INDICATIONS & USAGE

    ​Uses:​  ​Relieves sore throat pain, pain associated with canker sores, inflamed throat and mouth tissue, encourage healing of irritated mouth and throat sores and helps to reduce infection.

  • WARNINGS

    ​Warnings: Stop use and ask your dentist or doctor if swelling, rash or fever develops.

  • KEEP OUT OF REACH OF CHILDREN

    ​ ​Keep out of reach of children​Do not administer to children under 3 years of age unless directed by your doctor.​

  • DOSAGE & ADMINISTRATION

    ​Directions​​: For oral use only as directed by your health care professional. Shake gently prior to each use. Open mouth wide and insert applicator into mouth. Spray 2 to 3 pump sprays into mouth and throat area then swallow. Repeat every few hours or as needed.

  • SPL UNCLASSIFIED SECTION

    ​Other Information for cancer patients:​ ​ For use by cancer patients being treated with chemotherapy and/or radiation. For relief of lesions of the oral cavity associated with Muscositis. Safe and effective treatment for muscitis pain in patients with cancer. Spray in mouth, let stand for a few seconds then swallow.

  • SPL UNCLASSIFIED SECTION

    ​Other Information:​ ​ This formula is dark red in color and may temporarily color the mouth area. This is normal.

  • STORAGE AND HANDLING

    Store between 20-25 °C (68-77°F). Do not refrigerate

  • INACTIVE INGREDIENT

    ​Inactive Ingredients:​​ ​ Croton Lechleri, Deionized Water, Glycerin, Glycyrrhiza Leaf Extract, Honey, Lavandula Angustifolia Extract, Salvia Officinalis

  • PRINCIPAL DISPLAY PANEL

    thergy label

  • INGREDIENTS AND APPEARANCE
    THERGY 
    thymol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69148-002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL0.05 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CROTON LECHLERI WHOLE (UNII: 9K50DM06OR)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCYRRHIZA GLABRA LEAF (UNII: GH32M797Y9)  
    HONEY (UNII: Y9H1V576FH)  
    LAVANDULA ANGUSTIFOLIA WHOLE (UNII: 51217XIL5L)  
    SALVIA OFFICINALIS WHOLE (UNII: M9C36LC10E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69148-002-0015 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/09/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35603/09/2020
    Labeler - Anjon Biologics, Inc. (054126951)
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