THERGY- thymol spray

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)

Available from:

Anjon Biologics, Inc.

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

​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.

Authorization status:

OTC monograph not final

Summary of Product characteristics

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
thymol spray
PRODUCT INFORMATION
Anjon Biologics, Inc.
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