Sports Formula
FDA Label NDC 76524-302

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Protege' Media Llc for the product Sports Formula (NDC 76524-302). 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, indication:, warnings:, directions for use:, other information:, inactive ingredients:, comments, questions or complaints?, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients                                                                                                    Purpose

Arnica (A. montana) Tinc. 7% (70mg)HPUS                                                           Analgesic
Hemp extract (Cannabis sativa) 1X 7% (22.33mg) HPUS                                          Anti-inflammatory

Approximately 56 applications per container

Reference: the Homeopathic Pharmacopoeia of the United States (HPUS)

Indication:

Temporarily relieves pain associated with bruises, sore feet, muscle pain and strains

Warnings:

• For external use only. Not for use on open wounds.
• If symptoms persist or worsen, discontinue use, seek medical attention.
• Avoid contact with eyes. If product gets into eyes, flush with water, seek medical attention.
• If rash, redness, irritation or itching occurs, discontinue use.
• If pregnant or breastfeeding ask a health professional before use.
• If diagnosed with psychiatric or mood disorder, seek medical advice before use.
• If swallowed, get medical help or contact a Poison Center.
• Keep out of reach of children.

Directions For Use:

  • Liberally apply gel to affected area and rub into joints.
  • Use 3-4 times per day for the first week. Use as needed thereafter to relieve discomfort.
  • Use no more than 4 times per day.
  • Allow several days for product to take maximum effect.
  • Use within 60 days from opening. Store at 50° to 75°F (10°C to 24°C)

Other Information:

• Consult a medical professional if using other medications for known interactions.
• Cannabidiol in hemp extract may alter the metabolism of other drugs.

Inactive Ingredients:

Ethylglycerin, C13-14 isoparaffin, laureth-7, phenoxyethanol, polyacrylamide, purified water, tetrasodium EDTA, virgin olive oil, vitamin E

Product Label

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