Thergy
FDA Label NDC 69148-002

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Anjon Biologics, Inc. for the product Thergy (NDC 69148-002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Drug Facts

​​Active Ingredients

Thymol 0.05%

Otc - 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.

Otc - 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.

Other

​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.

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

Package Label.Principal Display Panel

Thergy Label (Thergy Label)

Thergy Label (Thergy Label)

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