FDA Label for Profoot Plantar Relief Strips

View Indications, Usage & Precautions

Profoot Plantar Relief Strips Product Label

The following document was submitted to the FDA by the labeler of this product Profoot Inc.. 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



Camphor 1.2%

Menthol 5.7%

Methyl salicylate 6.3%


Purpose



Topical Analgesic


Uses



For temporary relief of minor aches & pains of muscles & joints associated with: • arthritis • strains • bruises • sprains


Warnings



For external use only

Allergy alert:If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.


Do Not Use



• on wounds or damaged skin • with a heating pad • if you are allergic to any ingredients of this product


When Using This Product



• use only as directed • avoid contact with the eyes, mucocus membranes or rashes • do not bandage tightly


Stop Use And Ask A Doctor If



• rash, itching or excessive skin irritation develops • condtions worsen • symtomps persist for more than 7 days • symptoms clean up and occur again within a few days


If Pregnant Or Reach Of Children.



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


Keep Out Of Reach Of Children.



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


Directions



Adults and children 12 years of age and over:

• clean and dry affected area • hold patch wide end up to make a "I" shape • only peel off film on wide end first, stopping halfway • apply patch so that wings wrap around arch •remove remaing film & pull back to wrap around heel • apply to affected area not more than 3-4 times daily • remove patch from skin after at most 8 hours

Children under 12 years of age:consult a doctor 


Other Information



• avoid storing in direct sunlight • protect product from excessive moisture


Inactive Ingredients



hydrogenated poly, pentaerythrityl tetra-di-t-butyl Hydroxyhydrocinnamate, white mineral oil, styrene/Isoprene copolymer


Questions Or Comments?



Email [email protected]


* Please review the disclaimer below.