FDA Label for Cool And Heat Sore Muscle Roller Evora Labs

View Indications, Usage & Precautions

Cool And Heat Sore Muscle Roller Evora Labs Product Label

The following document was submitted to the FDA by the labeler of this product Evora Worldwide. 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 Ingredient                                               Purpose




Menthol 16% ..................................................... Topical analgesic


Uses



 temporarily relieves minor pain associated with:
• arthritis • simple backache • muscle strains • sprains • bruises• cramps


Warnings




For externa use only.
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 • redness is
present • irritation develops • symptoms persist for more than 7
days or clear up and occur again within a few days
Flammable • keep away from fire or flame
If pregnant or breast-feeding, ask a health professional before
use.


Keep Out Of Reach Of Children



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


Directions




adults and children over 12 years: • apply generously to
affected area • massage into painful area until thoroughly
absorbed into skin • repeat as necessary, but no more than 3 to 4
times daily • IF MEDICINE COMES IN CONTACT WITH HANDS,
WASH WITH SOAP AND WATER
Children 12 years or younger: ask a doctor


Inactive Ingredients



Acrylates/C10-30 Alkyl Acrylate
Crosspolymer, Capsaicin, Glycerin, lsopropyl Myristate, Propylene
Glycol, SD Alcohol 40 (30%), Triethanolamine, Water


Questions?



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