SPL v1
SPL
SPL Set ID 2dcd1db5-8bf1-4296-b280-b4e2012e649c
Route
TOPICAL
Published
Effective Date 2025-08-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Levomenthol (15 g)
Inactive Ingredients
Aconitum Carmichaelii Root Rehmannia Glutinosa Root Angelica Dahurica Root Paeonia Lactiflora Whole Lindera Aggregata Root Angelica Pubescens Root Rheum Officinale Root Chinese Cinnamon Aconitum Kusnezoffii Leaf Ampelopsis Japonica Tuber Angelica Sinensis Root Hansenia Forbesii Whole Licorice Scrophularia Ningpoensis Root Menthol, (+)- Myrrh Methyl Salicylate

Identifiers & Packaging

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

Description

Menthol 15%

Purpose

External analgesic


Medication Information

Purpose

External analgesic

Description

Menthol 15%

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 it and massage into affected areas.
  • Children under 12 years of age: consult your physician
Product Label

Other Information
  • Keep unused plasters in the pouch
  • Store in a cool dry place at room temperature.
Active Ingredients

Menthol 15%

Inactive Ingredients

Chuan Wu (Aconitum Carmichaelli Root), Di Huang (Rehmannia Glutinosa Root), Bai Zhi (Angelica Dahurica Root), Chi Shao (Paeonia Lactiflora Whole), Wu Yao (Lindera Aggregata Root), Du Huo (Angelica Pubescens Root), Da Huang (Rheum Officinale Root), Rou Gui Resin (Chinese Cinnamon), Cao Wu (Aconitum Kusnezoffii Leaf), Bai Lian (Ampelopsis Japonica Tuber), Dang Gui (Angelica Sinensis Root), Qiang Huo (Hansenia Forbsii Whole), Gan Cao (Licorice Root), Xuan Shen (Scrophularia Ningpoensis Root), Mo Yao (Myrrh), Ru Xiang (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 it and massage into affected areas.
  • Children under 12 years of age: consult your physician
Product Label (Product label)

Other Information
  • Keep unused plasters in the pouch
  • Store in a cool dry place at room temperature.
Active Ingredients

Menthol 15%

Inactive Ingredients (Inactive ingredients)

Chuan Wu (Aconitum Carmichaelli Root), Di Huang (Rehmannia Glutinosa Root), Bai Zhi (Angelica Dahurica Root), Chi Shao (Paeonia Lactiflora Whole), Wu Yao (Lindera Aggregata Root), Du Huo (Angelica Pubescens Root), Da Huang (Rheum Officinale Root), Rou Gui Resin (Chinese Cinnamon), Cao Wu (Aconitum Kusnezoffii Leaf), Bai Lian (Ampelopsis Japonica Tuber), Dang Gui (Angelica Sinensis Root), Qiang Huo (Hansenia Forbsii Whole), Gan Cao (Licorice Root), Xuan Shen (Scrophularia Ningpoensis Root), Mo Yao (Myrrh), Ru Xiang (Frankincense), Methyl Salicylate


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)