drug facts

drug facts
SPL v6
SPL
SPL Set ID 8d0cb441-4cc9-4225-abd5-e034a6b834b8
Route
topical
Published
Effective Date 2010-01-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (50 mg)

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2009-07-15
Description

Menthol (5%)

Medication Information

Warnings
  • For external use only. Do not use with a heating pad.  Do not apply to wounds or damaged skin. Do not bandage tightly after use.
  • Avoid contact with eyes.
  • Discontinue use and consult a physician if condition worsens, or if symptoms persist more than 7 days, or clear up and occur again within a few days.
  • Keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Active Ingredient

Menthol (5%)

Directions

Provides penetrating temporary relief for minor pain in muscles and joints associated with:

  • Backache
  • Arthritis
  • Bruises
  • Sprains
Inactive Ingredients

Water, Butylene Glycol, Prunus amygdalus dulcis (Sweet Almond) Oil, PEG-12 Glyceryl Distearate, Cetyl Alcohol, Glyceryl Stearate, Cyclomethicone, PEG-100 Stearate, Dimethicone, Aloe barbadensis Leaf Extract, Ehtylhexylglycerin, Carbomer, Caprylyl Glycol, Hexylene Glycol, Phenoxyethanol, Triethanolamine, Xanthan Gum.

Description

Menthol (5%)

Section 51945-4

Image: tube_shk10_1.jpg



Section 55105-1

Topical Analgesic

Structured Label Content

Warnings
  • For external use only. Do not use with a heating pad.  Do not apply to wounds or damaged skin. Do not bandage tightly after use.
  • Avoid contact with eyes.
  • Discontinue use and consult a physician if condition worsens, or if symptoms persist more than 7 days, or clear up and occur again within a few days.
  • Keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Active Ingredient (55106-9)

Menthol (5%)

Directions

Provides penetrating temporary relief for minor pain in muscles and joints associated with:

  • Backache
  • Arthritis
  • Bruises
  • Sprains
Inactive Ingredients

Water, Butylene Glycol, Prunus amygdalus dulcis (Sweet Almond) Oil, PEG-12 Glyceryl Distearate, Cetyl Alcohol, Glyceryl Stearate, Cyclomethicone, PEG-100 Stearate, Dimethicone, Aloe barbadensis Leaf Extract, Ehtylhexylglycerin, Carbomer, Caprylyl Glycol, Hexylene Glycol, Phenoxyethanol, Triethanolamine, Xanthan Gum.

Section 51945-4 (51945-4)

Image: tube_shk10_1.jpg



Section 55105-1 (55105-1)

Topical Analgesic

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:06.440615 · Updated: 2026-03-14T22:52:26.166879