FDA.reportPublic FDA data

Menthozen Cream

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 00:03:22

Label at a glance#

ProductMenthozen
Active ingredientMETHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, CAPSAICIN
Label structure7 sections

Indications and uses

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

Dosage and administration

Adults and children two-years of age or older: Apply to affected area not more than three to four times daily. Children under two-years of age: consult a physician.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate 20.00%

Menthol 5.00%

Capsaicin 0.0375%

OTC - PURPOSE SECTION

Topical Analgesic

USES:

INDICATIONS & USAGE SECTION

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

WARNINGS:

WARNINGS SECTION

  • For external use only.
  • Avoid contact with the eyes.
  • If condition worsens, or if symptoms persist for more than seven days or clear up and occur again with a few days, discontinue use of this product and consult a physician.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, consult physician.

Do not apply

OTC - DO NOT USE SECTION

  • to wounds or damaged skin.
  • Do not bandage tightly.

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

contact a physician prior to use.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults and children two-years of age or older: Apply to affected area not more than three to four times daily. Children under two-years of age: consult a physician.

OTHER INFORMATION:

SPL UNCLASSIFIED SECTION

Store at room temperature.

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetyl Alcohol, DMDM Hydantoin, Emulsifying Wax, Ethoxydiglycol, Ethylhexylglycerin, Glyceryl Stearate, Ilex Paraguayensis (Yerba Mate’) Extract, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polysorbate-20, Stearic Acid, Stearyl Alcohol, Triethanolamine, Xanthan Gum, Zemea (Corn) Propanediol.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

71205-153-72
71205-153-72

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1099896methyl salicylate 20 % / menthol 5 % / capsaicin 0.0375 % Topical CreamPSN6
1099896capsaicin 0.375 MG/ML / menthol 50 MG/ML / methyl salicylate 200 MG/ML Topical CreamSCD6
1099896capsaicin 0.0375 % / menthol 5 % / methyl salicylate 20 % Topical CreamSY6

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-153-72Menthozen120 mL in 1 BOTTLECREAM1206
71205-153-72Menthozen1 in 1 BOXCREAM16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-153MENTHOZEN (METHYL SALICYLATE, MENTHOL, CAPSAICIN) CREAM [PROFICIENT RX LP]6Current NDC, Legacy NDC, 2 package rows20231207_2adf3c4d-636f-4e02-b501-946b4df5f5d6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-153-72ML - Milliliter71205-15318f0e483-7e92-4104-97d6-9f030a975d4712019-02-13
71574-600-72ML - Milliliter71574-6000baa4962-4d7a-46b4-99cd-305ff66f507212019-01-24

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71205-15371205-153-72
71574-600

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
CETYL ALCOHOL936JST6JCNIACT
DMDM HYDANTOINBYR0546TOWIACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
PEG-100 STEARATEYD01N1999RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
STEARIC ACID4ELV7Z65APIACT
STEARYL ALCOHOL2KR89I4H1YIACT
TROLAMINE9O3K93S3TKIACT
XANTHAN GUMTTV12P4NEEIACT
METHYL SALICYLATELAV5U5022YACTIB
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
CAPSAICINS07O44R1ZMACTIB

Source Document#

Source XML · Source PDF

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
MenthozenMETHYL SALICYLATE, MENTHOL, CAPSAICINVillage Pharma LLC48b1b99e-d0ec-4e5c-b80c-c0d2d87ecb132026-01-01WarningsExact identifier
ndc (product): 71574-600
MenthozenMETHYL SALICYLATE, MENTHOL, CAPSAICINProficient Rx LP2adf3c4d-636f-4e02-b501-946b4df5f5d62023-12-01WarningsExact identifier
ndc (package): 71205-153-72
ndc (product): 71205-153
ndc11 (package): 71205015372
spl id: f17baf72-5a83-4b63-9ec3-2a3fb64bdd0e
spl set id: 2adf3c4d-636f-4e02-b501-946b4df5f5d6

Reported adverse events (FAERS/openFDA)#

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