FDA.reportPublic FDA data

WellPatch Warming Pain Relief

Manufacturer
The Mentholatum Company | Mentholatum China Pharmaceuticals Co. Ltd.
Effective date
2024-12-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:44:22

Label at a glance#

ProductWellPatch Warming Pain Relief
Active ingredientCAPSAICIN
Label structure9 sections

Indications and uses

temporarily relieves minor aches and pains of muscles and joints due to simple backache arthritis strains sprains

Dosage and administration

adults and children 12 years and over: apply to affected area; change patch 1 to 2 times daily children under 12 years: ask a doctor FOR BEST RESULTS: apply to clean, dry skin tear open pouch and remove patch; if desired, cut patch to size grasp both ends of the patch firmly with thumbs near center stretch patch until the backing separates remove protective film while applying patch directly to site of pain WASH H...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Capsaicin 0.025%

Purpose

OTC - PURPOSE SECTION

Capsaicin - Topical analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains of muscles and joints due to

  • simple backache
  • arthritis
  • strains
  • sprains

Warnings

WARNINGS SECTION

For external use only

  • use only as directed
  • do not use at least 1 hours before, or immediately after, a bath or shower
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or to damaged or very sensitive skin
  • do not bandage tightly or use with a heating pad

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • excessive redness, irritation, burning or discomfort of the skin develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days

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 and over: apply to affected area; change patch 1 to 2 times daily
  • children under 12 years: ask a doctor
  • FOR BEST RESULTS: apply to clean, dry skin
  • tear open pouch and remove patch; if desired, cut patch to size
  • grasp both ends of the patch firmly with thumbs near center
  • stretch patch until the backing separates
  • remove protective film while applying patch directly to site of pain
  • WASH HANDS WITH SOAP AND WATER AFTER APPLYING

Inactive ingredients

INACTIVE INGREDIENT SECTION

carboxymethylcellulose sodium, castor oil, dihydroxyaluminum aminoacetate, edetate disodium, glycerin, methylparaben, partially neutralized polyacrylate, polyacrylic acid, polysorbate 80, polyvinyl alcohol, propylene glycol monocaprylate, purified water, sodium polyacrylate, sodium polyacrylate starch, sorbitol solution, talc, tartaric acid

Questions or comments?

OTC - QUESTIONS SECTION

Toll free 1-877-636-2677 MON-FRI 9 AM to 5 PM (EST)

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WellPatch Warming Pain Relief PatchWellPatch Warming Pain Relief Patch

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug Facts
Drug Facts

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043399capsaicin 0.025 % Medicated PatchPSN4
1045382WellPatch CAPSAICIN 0.025 % Medicated PatchPSN4
1045382capsaicin 0.00025 MG/MG Medicated Patch [WellPatch]SBD4
1043399capsaicin 0.00025 MG/MG Medicated PatchSCD4
1043399capsaicin 0.025 % Medicated PatchSY4
1045382WellPatch 0.00025 MG/MG Medicated PatchSY4
1045382WellPatch 0.025 % Medicated PatchSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10742-8127-12023-02-07C16284748780-1f386c649-a85a-0266-e053-dadaa90a7c1aDrug Facts
10742-8127-22023-02-07C16284748780-1f386c649-a85a-0266-e053-dadaa90a7c1aDrug Facts
10742-8127-12023-01-30C16284748780-1f386c649-a85a-0266-e053-dadaa90a7c1aDrug Facts
10742-8127-22023-01-30C16284748780-1f386c649-a85a-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10742-8127-1WellPatch Warming Pain Relief1 in 1 POUCHPATCH14
10742-8127-2WellPatch Warming Pain Relief4 in 1 POUCHPATCH44

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10742-8127WELLPATCH WARMING PAIN RELIEF (CAPSAICIN) PATCH [THE MENTHOLATUM COMPANY]4Current NDC, Legacy NDC, 2 package rows20241219_ec583129-55fc-4ab1-94e5-9c900b5d95ef.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10742-812710742-8127-1, 10742-8127-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
CASTOR OILD5340Y2I9GIACT
DIHYDROXYALUMINUM AMINOACETATEDO250MG0W6IACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
POLYACRYLIC ACID (250000 MW)9G2MAD7J6WIACT
POLYSORBATE 806OZP39ZG8HIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
PROPYLENE GLYCOL CAPRYLATERT9P9S09QIIACT
WATER059QF0KO0RIACT
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
SORBITOL506T60A25RIACT
TALC7SEV7J4R1UIACT
TARTARIC ACIDW4888I119HIACT
CAPSAICINS07O44R1ZMACTIB

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
WellPatch Warming Pain ReliefCAPSAICINThe Mentholatum Companyec583129-55fc-4ab1-94e5-9c900b5d95ef2024-12-17WarningsExact identifier
ndc (package): 10742-8127-1
ndc (package): 10742-8127-2
ndc (product): 10742-8127
ndc11 (package): 10742812702
ndc11 (package): 10742812701
spl id: 2978dc6f-0b36-1e4d-e063-6294a90a4e4b
spl set id: ec583129-55fc-4ab1-94e5-9c900b5d95ef

Reported adverse events (FAERS/openFDA)#

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