Profoot Plantar Relief Strips

Manufacturer
Rooftop Consumer Health, Inc.
Effective date
2024-10-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:29:07

Label at a glance#

ProductProfoot Plantar Relief Strips
Active ingredientCAMPHOR (NATURAL), MENTHOL, METHYL SALICYLATE
Label structure8 sections

Indications and uses

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

Dosage and administration

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...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 1.2%

Menthol 5.7%

Methyl salicylate 6.3%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

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

Do not use

OTC - DO NOT USE SECTION

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

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

• 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Email cservice@profoot.co

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Profoot labelProfoot labelLabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
853260camphor 1.2 % / menthol 5.7 % / methyl salicylate 6.3 % Medicated PatchPSN2
853260camphor 0.012 MG/MG / menthol 0.057 MG/MG / methyl salicylate 0.063 MG/MG Medicated PatchSCD2
853260camphor 1.2 % / menthol 5.7 % / methyl salicylate 6.3 % Medicated PatchSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29784-602-01Profoot Plantar Relief Strips4 in 1 POUCHPATCH42
29784-602-01Profoot Plantar Relief Strips1 in 1 BOXPATCH12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29784-602PROFOOT PLANTAR RELIEF STRIPS (CAMPHOR (NATURAL), MENTHOL, METHYL SALICYLATE) PATCH [ROOFTOP CONSUMER HEALTH, INC.]2Current NDC, 2 package rows20241025_65e142d8-da21-4c55-9faf-b387cb6c2c0e.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
29784-60229784-602-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Profoot Plantar Relief StripsCAMPHOR (NATURAL), MENTHOL, METHYL SALICYLATERooftop Consumer Health, Inc.65e142d8-da21-4c55-9faf-b387cb6c2c0e2024-10-23WarningsExact identifier
ndc (package): 29784-602-01
ndc (product): 29784-602
ndc11 (package): 29784060201
spl id: 2529f702-e4dc-6c83-e063-6294a90ab89e
spl set id: 65e142d8-da21-4c55-9faf-b387cb6c2c0e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.