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Drug Facts
Distributed by Philia Group LLC
Address: 4 Flanders Drive, Pine Brook, NJ 07058
The following Structured Product Label (SPL) was submitted to the FDA by Philia Group Llc for the product Truu Balance Pain Relief (NDC 73596-100). 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 other, otc - purpose, uses, warnings, otc - do not use, stop use and ask doctor if, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Distributed by Philia Group LLC
Address: 4 Flanders Drive, Pine Brook, NJ 07058
| Active Ingredients | Purpose |
|---|---|
| Lidocaine 4% HCl w/w | External Analgesic |
| Menthol 1% w/w | External Analgesic |
For temporary relief of pain, burning, or itching where applied locally
For eternal use only
Avoid contact with eyes
Do not use in large quantities, particularly over raw surfaces or blistered areas
Keep out of reach of children
Apply in a circular motion for 30 to 60 seconds
For adults and children two-years and older: apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a physician.
Aqua (Deionized Water), Arnica Montana Flower Extract, C13-14 Isoparaffin, Chondroitin Sulfate, Emu Oil, Ethoxydiglycol, Ethylhexylglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Methylsulfonylmethane (MSM), Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid, Triethanolamine, Full Spectrum Hemp Extract. (Aerial Parts)
Protect this product from excessive heat and direct sunlight
FDA Registered: NDC No. _____-___-__
* Please review the disclaimer below.