SPL v1
SPL
SPL Set ID 621b167d-9b8d-4550-91c6-949840d3ab1c
Route
TOPICAL
Published
Effective Date 2025-08-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Levomenthol (5 g)
Inactive Ingredients
Clematis Terniflora Var. Mandshurica Root Momordica Cochinchinensis Seed Ricinus Communis Seed Myrrh Frankincense Methyl Salicylate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-23
Description

Menthol 5%

Purpose

External analgesic

Medication Information

Purpose

External analgesic

Description

Menthol 5%

Uses

Temporarily relieves muscle and joint pains: backaches, arthritis, strains, bruises, sprains

Warnings

For external use only

When using this product 

  • avoid contact with the eyes or mucous membranes 
  • do not use on wounds or broken skin

Stop use and ask a doctor if

  • conditions worsen 
  • excessive skin irritation develops
  • nausea, vomiting, abdominal discomfort, diarrhea, or a skin rash occurs
  • symptoms persists for more than 7 days

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • Adults and children 12 years of age and older: apply few drops into palm or hand nad massage into affected areas 
  • Children under 12 years of age: consult your physician
Product Label

Active Ingredients

Menthol 5%

Inactive Ingredients

CLEMATIS TERNIFLORA VAR. MANDSHURICA ROOT, MOMORDICA COCHINCHINENSIS SEED, RICINUS COMMUNIS SEED, MYRRH, FRANKINCENSE, METHYL SALICYLATE

Structured Label Content

Uses

Temporarily relieves muscle and joint pains: backaches, arthritis, strains, bruises, sprains

Purpose

External analgesic

Warnings

For external use only

When using this product 

  • avoid contact with the eyes or mucous membranes 
  • do not use on wounds or broken skin

Stop use and ask a doctor if

  • conditions worsen 
  • excessive skin irritation develops
  • nausea, vomiting, abdominal discomfort, diarrhea, or a skin rash occurs
  • symptoms persists for more than 7 days

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • Adults and children 12 years of age and older: apply few drops into palm or hand nad massage into affected areas 
  • Children under 12 years of age: consult your physician
Product Label (Product label)

Active Ingredients

Menthol 5%

Inactive Ingredients (Inactive ingredients)

CLEMATIS TERNIFLORA VAR. MANDSHURICA ROOT, MOMORDICA COCHINCHINENSIS SEED, RICINUS COMMUNIS SEED, MYRRH, FRANKINCENSE, METHYL SALICYLATE

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:49.817308 · Updated: 2026-03-14T23:09:50.407692