Thergy by Anjon Biologics Inc. THERGY- thymol spray

Thergy by

Drug Labeling and Warnings

Thergy by is a Otc medication manufactured, distributed, or labeled by Anjon Biologics Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

THERGY 
thymol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69148-002
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)	THYMOL	0.05 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69148-002-00	15 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/09/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	03/09/2020

Labeler - Anjon Biologics, Inc. (054126951)