MedPath

Menthol pain relief patches

Approved
Approval ID

3b5fd718-3f86-f7a7-e063-6294a90a8c52

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 2, 2025

Manufacturers
FDA

Menthol pain relief patch

DUNS: 456434537

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Menthol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code84876-005
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
Menthol
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 2, 2025
FDA Product Classification

INGREDIENTS (10)

CAPSAICINActive
Quantity: 0.25 g in 100 g
Code: S07O44R1ZM
Classification: ACTIB
SODIUM POLYACRYLATE (2500000 MW)Inactive
Code: 05I15JNI2J
Classification: IACT
MENTHOLActive
Quantity: 5 g in 100 g
Code: L7T10EIP3A
Classification: ACTIB
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLUCOSAMINEInactive
Code: N08U5BOQ1K
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
DIHYDROXYALUMINUM AMINOACETATEInactive
Code: DO250MG0W6
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/1/2025

labeling

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/1/2025

i adults and children 12 years of age and older: Clean and dry affected area, pop apartand partiallypeel back protective film and apply exposed patch to site of pain. Carefullyremove remaining filmwhile pressing the patch to skin and leave in place for up to 8hours. Use on affected area not morethan 3 to 4 times daily.children under 12 years of age: consult a physicianwash hands after use with cool water

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/1/2025

Keep out of reach of children. lfswallowed, get medical help or contact a Poison ControlCenter right away.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/1/2025

Menthol 5%
Capsaicin 0.25%.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/1/2025

Uses
Temporarily relieves minor aches and pains of muscles and joints associated with:simple backache, arthritis
,strains,bruises,sprains

WARNINGS SECTION

LOINC: 34071-1Updated: 8/1/2025

WarningsFor externaluse only.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 8/1/2025

use only as directed avoid contact with the eyes or on mucous membranes

do not apply to wounds or damaged skin

do not apply to irritated skin or if excessive irritation

do not bandage tightly or use with heating pad or device

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 8/1/2025

you experience pain, swelling or blistering of the skinicondition worsens, or if symptoms persist for more than 7 days or clear up and occuragain within afew daysarthritic pain persists for more than 10 days, or redness is present

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/1/2025

Carefullyremove remaining filmwhile pressing the patch to skin and leave in place for up to 8hours. Use on affected area not morethan 3 to 4 times daily

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/1/2025

Inactive ingredients
Sodium polyacrylate,Aluminium glycinat,Disodium edetate dihydrate,Purified water,Tartaric acid ,polyving alcohol,Glucosamine,gl ycerol.

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Menthol pain relief patches - FDA Drug Approval Details