THERGY- thymol spray 
Anjon Biologics, Inc.

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.

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ANJON BIOLOGICS - THERGY (69148-002)

Drug Facts

​Active Ingredients

Thymol 0.05%

​Purpose

Oral Analgesic/Antimicrobial

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

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

​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.

​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.

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

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

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

thergy label

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)

Revised: 2/2022
Document Id: d6fed19f-8f02-bfb4-e053-2a95a90a7fc6
Set id: fd31d290-8d33-4cec-8767-f9c20f5f067f
Version: 3
Effective Time: 20220201
 
Anjon Biologics, Inc.