FDA.reportPublic FDA data

5% Menthol Pain Relief Patch

Manufacturer
Xuzhou Lanting Pharmaceutical Co., Ltd
Effective date
2025-06-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:11:43

Label at a glance#

Product5% Menthol Pain Relief Patch
Active ingredientMENTHOL
Label structure1 sections

Label contents#

Full prescribing information#

5% Menthol Pain Relief Patch, Package NDC Code 85323-007-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5% Menthol Pain Relief Patch, Package NDC Code 85323-007-01

5 Menthol Pain Relief Patch 85323-007-015 Menthol Pain Relief Patch 85323-007-01

82635 cold hot medicated patch - pouch82635 cold hot medicated patch - pouch

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Menthol 5%

Purpose

OTC - PURPOSE SECTION

Purpose: Topical anesthetic

Warnings

WARNINGS SECTION

For external use only.

  • Do not use
  • more than 1 patch at a time
  • 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
  • do not bandage tightly or use with a heating pad
  • avoid contact with the eyes and mucous membranes
  • do not apply to wounds or damaged skin.

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few day
  • redness is present
  • skin irritation develops

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

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 (1-800-222-1222) immediately.

Other information

OTHER SAFETY INFORMATION

Other Information

  • store at roo temperature 68 to 77℉ (20 to 25℃)

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

Adult and children 12 years of age and older:

  • peel off protective backing and apply sticky side to affected area
  • carefully remove backing from patch
  • should be used to 8 hours
  • ashould be used no more than 3 times a day
  • Children under 12 years of age: consult a doctor

Uses

DESCRIPTION SECTION

Uses

Temporarily relieve minor aches and pains of muscles and joints due to

  • simple backache
  • arthritis
  • muscle strains
  • bursitis
  • tendonitis
  • muscle sprains
  • bruises
  • cramps

INDICATIONS & USAGE SECTION

Temporarily relieves minor pains associated with:

  • arthritis
  • simple backache
  • muscle strains
  • bursitis
  • tendonitis
  • sprains
  • bruises
  • cramps

Adult and Children 12 years of age and older:

  • peel off protective backing and apply sticky side to affected area
  • carefully remove backing from patch
  • should be used to 8 hours
  • ashould be used no more than 3 times a day
  • Children under 12 years of age: consult a doctor

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
420222menthol 5 % Medicated PatchPSN3
420222menthol 0.05 MG/MG Medicated PatchSCD3
420222menthol 5 % Medicated PatchSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85323-007-015% Menthol Pain Relief Patch24 in 1 BOXPATCH243
85323-007-015% Menthol Pain Relief Patch1 in 1 POUCHPATCH13

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85323-00785323-007-01

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
POLYSORBATE 806OZP39ZG8HIACT
KAOLIN24H4NWX5COIACT
MENTHOLL7T10EIP3AACTIB
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
CARBOMER 934Z135WT9208IACT
GLYCERINPDC6A3C0OXIACT
DMDM HYDANTOINBYR0546TOWIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
EDETATE DISODIUM7FLD91C86KIACT
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS1K713C615KIACT
POVIDONE K90RDH86HJV5ZIACT
TARTARIC ACIDW4888I119HIACT
ALCOHOL 95%7528N5H79BIACT

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
5% Menthol Pain Relief PatchPAIN RELIEF PATCHXuzhou Lanting Pharmaceutical Co., Ltd37ea68d7-5c1f-cec8-e063-6294a90a709d2025-06-10WarningsExact identifier
ndc (package): 85323-007-01
ndc (product): 85323-007
ndc11 (package): 85323000701
spl id: 3d3c49cb-9c8d-a9a2-e063-6394a90ac6ee
spl set id: 37ea68d7-5c1f-cec8-e063-6294a90a709d

Reported adverse events (FAERS/openFDA)#

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