Premium Hemp Pain Relief
FDA Label NDC 54723-201

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sambria Pharmaceuticals Inc. for the product Premium Hemp Pain Relief (NDC 54723-201). 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 active ingredients, purpose, uses, warnings, do not use, stop use and ask doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Lidocaine 4.0%

Menthol 1%

Purpose

External Analgesic

Uses

For temporary relief of pain and itching due to minor skin irritation.

Warnings

For external use only

Avoid contact with eyes

Do Not Use

in large quantities, particularly over raw surfaces or blistered areas

Stop Use And Ask Doctor If

Condition worsens or, if symptoms persist for more than 7 days or clear up and occur again within a few days. Discontinue use.

Keep Out Of Reach Of Children

If product is swallowed get medical help or contact a Poison Control Center right away.

Directions

For adults and children two-years or older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a physician. Apply in a circular motion for 30 to 60 seconds.

Inactive Ingredients

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

Other Information

Protect this product from excessive heat and direct sun.

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