Profoot Pain Relief Patches

Manufacturer
Profoot, Inc.
Effective date
2024-10-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:28:42

Label at a glance#

ProductProfoot Pain Relief Patches
Active ingredientMETHYL SALICYLATE, CAMPHOR (NATURAL), MENTHOL
Label structure10 sections

Storage and handling

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Camphor 1.2%

Menthol 5.7%

Methyl salicylate 6.3%

OTC - PURPOSE SECTION

Purpose

Topical Analgesic

Topical Analgesic

Topical Analgesic

INDICATIONS & USAGE SECTION

Uses For temporary relief of minor aches & pains of muscles & joints associated with:

•arthritis •strains •bruises •sprains

WARNINGS SECTION

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 SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control

Center right away

DOSAGE & ADMINISTRATION SECTION

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 SECTION

Other information

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

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

Questions or comments? Email cservice@profoot.co

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label InnerLabel InnerLabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
853260camphor 1.2 % / menthol 5.7 % / methyl salicylate 6.3 % Medicated PatchPSN3
853260camphor 0.012 MG/MG / menthol 0.057 MG/MG / methyl salicylate 0.063 MG/MG Medicated PatchSCD3
853260camphor 1.2 % / menthol 5.7 % / methyl salicylate 6.3 % Medicated PatchSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29784-121-36Profoot Pain Relief Patches0.36 g in 1 PATCHPATCH0.36 g63 mg in 1g3
29784-122-36Profoot Pain Relief Patches1.3 g in 1 PATCHPATCH1.3 g63 mg in 1g3
29784-601-01Profoot Pain Relief Patches1 in 1 KITKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29784-121PROFOOT PAIN RELIEF PATCHES (CAMPHOR, MENTHOL, METHYL SALICYLATE) KIT [PROFOOT, INC.]3Legacy NDC20241025_06f82bde-41a1-35f6-e063-6394a90a6437.zip
29784-122PROFOOT PAIN RELIEF PATCHES (CAMPHOR, MENTHOL, METHYL SALICYLATE) KIT [PROFOOT, INC.]3Legacy NDC20241025_06f82bde-41a1-35f6-e063-6394a90a6437.zip
29784-601PROFOOT PAIN RELIEF PATCHES (CAMPHOR, MENTHOL, METHYL SALICYLATE) KIT [PROFOOT, INC.]3Current NDC, 3 package rows20241025_06f82bde-41a1-35f6-e063-6394a90a6437.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
29784-60129784-601-01
29784-12129784-121-36
29784-12229784-122-36

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Profoot Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATERooftop Consumer Health, Inc.cc011b79-2761-40f7-8142-88f8e30a179a2024-10-23WarningsExact identifier
ndc (package): 29784-121-36
ndc (package): 29784-122-36
ndc11 (package): 29784012236
ndc11 (package): 29784012136
Profoot Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEProfoot, Inc.06f82bde-41a1-35f6-e063-6394a90a64372024-10-23WarningsExact identifier
ndc (package): 29784-121-36
ndc (package): 29784-122-36
ndc (package): 29784-601-01
ndc (product): 29784-601
ndc11 (package): 29784060101
ndc11 (package): 29784012236
ndc11 (package): 29784012136
spl id: 252a0dfe-c0dc-640c-e063-6394a90a999b
spl set id: 06f82bde-41a1-35f6-e063-6394a90a6437

Reported adverse events (FAERS/openFDA)#

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