FDA.reportPublic FDA data

Menthozen Hydrogel Patch

Manufacturer
Proficient Rx LP
Effective date
2023-12-01
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:03:28

Label at a glance#

ProductMenthozen Hydrogel
Active ingredientMENTHOL, UNSPECIFIED FORM, CAPSAICIN
Label structure7 sections

Indications and uses

For temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

Dosage and administration

Adults and children 12-years and over: Apply to affected area; change patch 1-2 times dily. Children under 12, consult a physician before use. How to Apply : Remove patch from backing and apply directly to area of pain. Do not apply to affected area more than three times daily. Use only one patch at a time. Wash hands with soap and water immediately after application. Reseal pouch containg unused patches. 

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Menthol 4.00%

Capsaician 0.03%

OTC - PURPOSE SECTION

External Analgesic

USES:

INDICATIONS & USAGE SECTION

For temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

WARNINGS:

WARNINGS SECTION

For external use only. Use only as directed.

  • Avoid contact with eyes and mucous membranes.
  • Do not apply to open wounds or damaged skin.

Do not use

OTC - DO NOT USE SECTION

  • in combination with any external heat source.
  • Do not use on irritated or broken skin, or use in combination with any bandage, wrap, stocking or similar device or garment.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Do not use if allergic to Menthol.

Stop use and consult physician

OTC - STOP USE SECTION

  • if symptoms worsen or persist for more than 7 days.
  • Stop use if itching or excessive skin irritation occurs.

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

  • contact physician prior to use

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults and children 12-years and over: Apply to affected area; change patch 1-2 times dily.

Children under 12, consult a physician before use.

How to Apply:

Remove patch from backing and apply directly to area of pain.

Do not apply to affected area more than three times daily.

Use only one patch at a time.

Wash hands with soap and water immediately after application.

Reseal pouch containg unused patches. 

OTHER INFORMATION:

SPL UNCLASSIFIED SECTION

Store below 25 degrees Celsius. Avoid direct sunlight.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Aqua (Deionized Water), Sodium Polyacrylate, Glycerol, D-Glucitrol, Sodium Cellulose Glycolate, Polysorbate-80, Lemon Oil, Aluminum Glycinate, Methylparaben, EDTA Disodium Salt

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

71205-334-30
71205-334-30

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2178283capsaicin 0.03 % / menthol 4 % Medicated PatchPSN6
2178283capsaicin 0.0003 MG/MG / menthol 0.04 MG/MG Medicated PatchSCD6
2178283capsaicin 0.03 % / menthol 4 % Medicated PatchSY6

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-334-05Menthozen Hydrogel5 in 1 POUCHPATCH56
71205-334-05Menthozen Hydrogel1 g in 1 PATCHPATCH16
71205-334-15Menthozen Hydrogel1 g in 1 PATCHPATCH16
71205-334-15Menthozen Hydrogel15 in 1 POUCHPATCH156
71205-334-30Menthozen Hydrogel1 g in 1 PATCHPATCH16
71205-334-30Menthozen Hydrogel30 in 1 POUCHPATCH306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-334MENTHOZEN HYDROGEL (MENTHOL, CAPSAICIN) PATCH [PROFICIENT RX LP]6Current NDC, Legacy NDC, 6 package rows20231207_85a7809e-c43f-4138-a85b-44e1b586def5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-334-05EA - Each71205-3348ebe78c4-2a9d-4463-8852-5899b2e17c3512021-02-05
71205-334-15EA - Each71205-33487828063-afb9-4749-9f52-6c85aaf0ff0112019-11-12
71205-334-30EA - Each71205-33418a3e94d-b288-47ef-bfdf-b0ffb7facccc12019-11-12
71574-601-05EA - Each71574-6014377734f-5d5c-489f-a568-ca35c380689112019-10-07

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71205-33471205-334-05, 71205-334-15, 71205-334-30
71574-601

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
POLYSORBATE 806OZP39ZG8HIACT
LEMON OIL, COLD PRESSEDI9GRO824LLIACT
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS1K713C615KIACT
METHYLPARABENA2I8C7HI9TIACT
EDETATE DISODIUM7FLD91C86KIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Menthozen HydrogelMENTHOL, CAPSAICINVillage Pharma LLC4c979a71-7c8f-4dff-abae-bf4cdf8f67b42026-01-01WarningsExact identifier
ndc (product): 71574-601
Menthozen HydrogelMENTHOL, CAPSAICINProficient Rx LP85a7809e-c43f-4138-a85b-44e1b586def52023-12-01WarningsExact identifier
ndc (package): 71205-334-15
ndc (package): 71205-334-05
ndc (package): 71205-334-30
ndc (product): 71205-334
ndc11 (package): 71205033405
ndc11 (package): 71205033430
ndc11 (package): 71205033415
spl id: 1cdc9d1f-d8eb-40e4-99e6-286c7dbfb986
spl set id: 85a7809e-c43f-4138-a85b-44e1b586def5

Reported adverse events (FAERS/openFDA)#

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