Active Ingredient
Menthol ---10.5%
Total Muscle Relief
FDA Label NDC 50130-109
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Electrostim Medical Services Inc. D/b/a Emsi for the product Total Muscle Relief (NDC 50130-109). 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, otc - keep out of reach of children, directions, inactive ingredients, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Cooling Pain Relief
Uses
Temporary relief from minor aches and pains of sore muscles and joints associated with arthrilis backaches strains and sprains
Warnings
For external use only.
Flammable; Keep away from excessive heat or open-flame.
Ask doctor before use if you have: Sensitive skin.
When using this product: Avoid contact with the eyes or mucus membranes. Do not apply to wounds or damaged skin. Do not use with other ointments, creams, sprays or liniments. Do not apply to irritated skin of if excessive irritation develops. Do not bandage. Wash hand after use with cold water. Do not use heating pads or device. Store in a cool dry place. Stop use and ask doctor if: condition worsens or if symptoms persist for more than 7 days or clear up and recur.
If pregnant or breast feeding: ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children: if accidently ingested get medical help or contact Poison Control Center immediately
Directions
Adult and children 12 years of age and older: Spray on to the affected areas not more than four times daily. Massage not necessary.
Children under 12 years of age: Consult physician.
Inactive Ingredients
Purified water, Extract of Aloe Vera, Witch Hazel, Water Cress and Rosemary, Isopropanol, Glycerin, Polysorbate 20, Coconut Oil, Sweet Almond Oil, Emu Oil
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