FDA.reportPublic FDA data

5% Menthol Pain Relief Patch

Manufacturer
Xuzhou Lanting Pharmaceutical Co., Ltd
Effective date
2025-03-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:11:42

Label at a glance#

Product5% Menthol Pain Relief Patch
Active ingredientLEVOMENTHOL
Label structure1 sections

Label contents#

Full prescribing information#

5% Menthol Pain Relief Patch, Package NDC Code 85323-004-00

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5% Menthol Pain Relief Patch, Package NDC Code 85323-004-00

5 Menthol Pain Relief Patch 85323-004-00.jpg5 Menthol Pain Relief Patch 85323-004-00.jpg

Warnings

WARNINGS SECTION

Warnings (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
  • avoid contact with the eyes, mucous membranes or rashes
  • do not bandage tightly

Stop use and ask a doctor if

  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

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 right away.

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.

Other information

OTHER SAFETY INFORMATION

  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture

DOSAGE & ADMINISTRATION SECTION

Adult and children 12 years of age and over:
clean and dry affected area
remove film from patch and apply to the skin (see illustration)
apply 1 patch at a time to affected area, not more than 3 to 4 times daily
remove patch from the skin after at most 8-hour application


Children under 12 years of age: consult a doctor

Uses

DESCRIPTION SECTION

Temporarily relieves minor pains associated with:

arthritis

simple backache

bursitis

tendonitis

muscle strains

sprains

bruises

cramps

Directions

INDICATIONS & USAGE SECTION

Uses For temporary relieves minor pains associated with:

arthritis
simple backache
bursitis
tendonitis
muscle strains
sprains
bruises
cramps

Adult and children 12 years of age and over:

clean and dry affected area

remove film from patch and apply to the skin (see illustration)

apply 1 patch at a time to affected area, not more than 3 to 4 times daily

remove patch from the skin after at most 8-hour application

Children under 12 years of age: consult a doctor

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
420222menthol 5 % Medicated PatchPSN4
420222menthol 0.05 MG/MG Medicated PatchSCD4
420222menthol 5 % Medicated PatchSY4

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
85323-004-005% Menthol Pain Relief Patch5 in 1 BOXPATCH54
85323-004-005% Menthol Pain Relief Patch1 in 1 POUCHPATCH14

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
85323-00485323-004-00

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
LEVOMENTHOLBZ1R15MTK7ACTIB
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
CARBOMER0A5MM307FCIACT
GLYCERINPDC6A3C0OXIACT
DMDM HYDANTOINBYR0546TOWIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
EDETATE DISODIUM7FLD91C86KIACT
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS1K713C615KIACT
POVIDONE K90RDH86HJV5ZIACT
TARTARIC ACIDW4888I119HIACT

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., Ltd2f991134-b127-1832-e063-6394a90aef552025-03-01WarningsExact identifier
ndc (package): 85323-004-00
ndc (product): 85323-004
ndc11 (package): 85323000400
spl id: 3d3c1591-3e54-e73a-e063-6294a90a7a88
spl set id: 2f991134-b127-1832-e063-6394a90aef55

Reported adverse events (FAERS/openFDA)#

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