FDA Label for Profoot Pain Relief Patches
View Indications, Usage & Precautions
Profoot Pain Relief Patches 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.
Otc - Active Ingredient
Active ingredients
Camphor 1.2%
Menthol 5.7%
Methyl salicylate 6.3%
Otc - Purpose
Purpose
Topical Analgesic
Topical Analgesic
Topical Analgesic
Indications & Usage
Uses For temporary relief of minor aches & pains of muscles & joints associated with:
•arthritis •strains •bruises •sprains
Warnings
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 of the ingredients of
this product
When using this product
• use only as directed • avoid contact with the eyes, mucous membranes or rashes • do not
bandage tightly
Stop use and ask a doctor if
• rash, itching or excessive skin irritation develops • condition worsens •symptoms persist
for more than 7 days • symptoms clear up and occur again within a few days
If pregnant or breastfeeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control
Center right away
Dosage & Administration
Directions
Adults and children 12 years of age and over:
• clean and dry affected area • remove patch from film • 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
Storage And Handling
Other information
• avoid storing in direct sunlight • protect product from excessive moisture
Inactive Ingredient
Inactive ingredients hydrogenated poly, pentaerythrityl tetra-di-t-butyl Hydroxyhydrocinnamate, white mineral oil, styrene/Isoprene copolymer
Otc - Questions
Questions or comments? Email [email protected]
* Please review the disclaimer below.