FDA Label for Cool And Heat Sore Muscle Roller
View Indications, Usage & Precautions
Cool And Heat Sore Muscle Roller Product Label
The following document was submitted to the FDA by the labeler of this product Acutens. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients Purpose
Menthol 16% Topical Analgesic
Uses:
Temporary relief of minor aches pains of muscles and joints associated with arthritis, simple backache, strains, bruises, and sprains
Warnings For External Use Only
Flammable: Keep away from fire or flame.
When using this product • use only as directed • do not bandage tightly or use with a heating pad • avoid contact with eyes and mucous membranes • do not apply to wounds or damaged, broken or irritated skin • a transient burning sensation may occur upon application but generally disappears in several days • if severe burning sensation occurs, discontinue use immediately • do not expose the area treated with product to heat or direct sunlight.
Stop use and ask doctor if • condition worsens •symptoms persist for more than 7 days or clear up and occur again within a few days
If pregnant or breast-feeding, ask a health professional before use.
Direction
• Adults and children 2 years of age and older: apply to affected area not more than 3-4 times daily
• Children under 2 years old: consult apfysician
Inactive Ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer
Capsaicin
Glycerin
Isopropyl Myristate
Propylene Glycol
SD Alcohol 40 (30.0%)
Triethanolamine
Water
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