FDA.reportPublic FDA data

Menthol, Capsaicin

Manufacturer
MAS Management Group Inc.
Effective date
2016-08-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:47:01

Label at a glance#

ProductMenthol, Capsaicin
Active ingredientCAPSAICIN, MENTHOL
Label structure10 sections

Indications and uses

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

Dosage and administration

Adults and children 12 years and over apply to affected area; change patch 1 to 2 times daily. Children under 12years, consult physician before use Clean and dry affected area Remove protective film and apply directly to area of pain Apply to affected area not more than 3 times daily Wash hands with soap after applying patch Reseal pouch containing unused patches

Storage and handling

Store in dry area between 59-79 F(15-26 C)

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Menthol 5%

PURPOSE

OTC - PURPOSE SECTION

External Analgesic

USES

INDICATIONS & USAGE SECTION

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

WARNINGS

WARNINGS SECTION

  • For external use only.
  • Use only as directed.
  • Avoid contact with eyes and mucous membranes.
  • Do not cover with bandage.
  • Do not use on wounds or damaged skin.
  • Do not use in combination with any other external analgesic products.
  • 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

Consult physician for children under 12.

If swallowed, get a medical help or contact Poison Control Center right away.

Pregnancy or Breast Feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

DIRECTIONS

INSTRUCTIONS FOR USE SECTION

  • Adults and children 12 years and over apply to affected area; change patch 1 to 2 times daily.
  • Children under 12years, consult physician before use
  • Clean and dry affected area
  • Remove protective film and apply directly to area of pain
  • Apply to affected area not more than 3 times daily
  • Wash hands with soap after applying patch
  • Reseal pouch containing unused patches

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER, GLYCERINE, SODIUM POLYACRYLATE, POLYSORBATE 80, ALOE BARBADESIS LEAF (ALOE VERA
GEL) JUICE, EDTA DISODIUM SALT, DIAZOLIDINYL UREA, METHYLPARABEN, LODOPROYNYL BUTYLCABAMATE, PROPYLPARABEN.

Storage and Handling

STORAGE AND HANDLING SECTION

Store in dry area between 59-79 F(15-26 C)

Questions or Comments

OTC - QUESTIONS SECTION

Please call (800) 768-3518

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and over apply to affected area; change patch 1 to 2 times daily.

Children under 12years, consult physician before use.

VitaCin Patch

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Vitacin PatchVitacin Patch

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1300889capsaicin 0.0375 % / menthol 5 % Medicated PatchPSN1
1300889capsaicin 0.000375 MG/MG / menthol 0.05 MG/MG Medicated PatchSCD1
1300889capsaicin 0.0375 % / menthol 5 % Medicated PatchSY1

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69677-011-152020-01-31C16284748780-19d75b9d1-2748-f424-e053-dadaa90a57ce3b4d9084-612b-1049-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69677-011-15Menthol, Capsaicin8 g in 1 PATCHPATCH81
69677-011-15Menthol, Capsaicin15 in 1 BOXPATCH151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69677-011MENTHOL, CAPSAICIN (VITACIN) PATCH [MAS MANAGEMENT GROUP INC.]1Legacy NDC, 2 package rows20160908_3b4d9084-612b-1049-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69677-01169677-011-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAPSAICINS07O44R1ZMACTIB
EDETATE DISODIUM7FLD91C86KIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
MENTHOLL7T10EIP3AACTIB
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT

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
3b4d9084-612c-1049-e054-00144ff8d46c3b4d9084-612b-1049-e054-00144ff8d46c2016-08-30WarningsExact identifier
spl id: 3b4d9084-612c-1049-e054-00144ff8d46c
spl set id: 3b4d9084-612b-1049-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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