Profoot Plantar Relief Strips Patch
FDA Label NDC 29784-602

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rooftop Consumer Health, Inc. for the product Profoot Plantar Relief Strips (NDC 29784-602). 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 ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, if pregnant or reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

Package Labeling:

Label (Label)

Label (Label)

* Please review the disclaimer below.