SPL v1
SPL
SPL Set ID 3b4d9084-612b-1049-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2016-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.375 mg) Menthol (50 mg)
Inactive Ingredients
Edetate Disodium Diazolidinyl Urea Water Glycerin Methylparaben Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-09-01
Description

Menthol 5%

Purpose

External Analgesic

Storage and Handling

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

Medication Information

Purpose

External Analgesic

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.

Storage and Handling

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

Description

Menthol 5%

Uses

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

Warnings
  • 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.
Directions
  • 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
Vitacin Patch

Active Ingredients

Menthol 5%

Inactive Ingredients

WATER, GLYCERINE, SODIUM POLYACRYLATE, POLYSORBATE 80, ALOE BARBADESIS LEAF (ALOE VERA

GEL) JUICE, EDTA DISODIUM SALT, DIAZOLIDINYL UREA, METHYLPARABEN, LODOPROYNYL BUTYLCABAMATE, PROPYLPARABEN.

Questions Or Comments

Please call (800) 768-3518

Pregnancy Or Breast Feeding

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

Keep Out of Reach of Children

Consult physician for children under 12.

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

Structured Label Content

Uses (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 (34068-7)

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.

Purpose (PURPOSE)

External Analgesic

Warnings (WARNINGS)
  • 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.
Directions (DIRECTIONS)
  • 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
Vitacin Patch (VitaCin Patch)

Active Ingredients (ACTIVE INGREDIENTS)

Menthol 5%

Inactive Ingredients (INACTIVE INGREDIENTS)

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

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

Questions Or Comments (Questions or Comments)

Please call (800) 768-3518

Pregnancy Or Breast Feeding (Pregnancy or Breast Feeding)

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

Keep Out of Reach of Children (Keep out of reach of children)

Consult physician for children under 12.

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:10.152592 · Updated: 2026-03-14T22:54:26.235755