Muscle Gel
FDA Label NDC 59898-805

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Water-jel Technologies for the product Muscle (NDC 59898-805). 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 ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, keep out of the 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 Ingredient

Menthol 3.5%

Purpose

External analgesic

Uses

for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains

Warnings

For external use only

Directions

  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: consult a doctor

Other Information

  • store at room temperature
  • apply product directly onto sore areas of the body
  • massage well for best results
  • following application, wash hands well and rinse with cool water

Inactive Ingredients

aloe barbadensis leaf juice, angelica archangelica root extract, camphor, carbomer, DMDM hydantoin, isopropyl alcohol, methylparaben, panax ginseng root extract, purified water, triethanolamine

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