SPL v1
SPL
SPL Set ID c56241b3-ef7a-40ee-a89a-754a580b0118
Route
TOPICAL
Published
Effective Date 2025-07-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Levomenthol (5.1 g)
Inactive Ingredients
Aconitum Carmichaelii Root Aconitum Kusnezoffii Leaf Rehmannia Glutinosa Root Ampelopsis Japonica Tuber Angelica Dahurica Root Angelica Sinensis Root Paeonia Lactiflora Whole Hansenia Forbesii Whole Lindera Aggregata Root Licorice Angelica Pubescens Root Scrophularia Ningpoensis Root Rheum Officinale Root Solidago Virgaurea Flowering Top Methyl Salicylate

Identifiers & Packaging

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

Description

Menthol 5.1%

Purpose

External analgesic


Medication Information

Purpose

External analgesic

Description

Menthol 5.1%

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: cut plaster to ideal size, remove clear film and apply to affected area
  • Avoid over 8 hours of continuous usage or consult your physician
  • Do not apply on extermely hairy skin
  • Wet the patch with warm water before removing
  • 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 5.1%

Inactive Ingredients

Chuan Wu ACONITUM CARMICHAELII ROOT, Cao Wu (ACONITUM KUSNEZOFFII LEAF), Di Huang - Radix Rehmanniae, Bai Lian AMPELOPSIS JAPONICA TUBER, Bai Zhi - ANGELICA DAHURICA ROOT, Dang Gui (ANGELICA SINENSIS ROOT), Chi Shao whole PAEONIA LACTIFLORA WHOLE, Qiang Huo whole (HANSENIA FORBESII WHOLE, Wu Yao - LINDERA AGGREGATA ROOT, Gan Cao (LICORICE), Du Huo (ANGELICA PUBESCENS ROOT), Xuan Shen (SCROPHULARIA NINGPOENSIS ROOT), Da Huang ( RHEUM OFFICINALE ROOT), Liu Zhi (SOLIDAGO VIRGAUREA FLOWERING TOP, 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: cut plaster to ideal size, remove clear film and apply to affected area
  • Avoid over 8 hours of continuous usage or consult your physician
  • Do not apply on extermely hairy skin
  • Wet the patch with warm water before removing
  • 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 5.1%

Inactive Ingredients (Inactive ingredients)

Chuan Wu ACONITUM CARMICHAELII ROOT, Cao Wu (ACONITUM KUSNEZOFFII LEAF), Di Huang - Radix Rehmanniae, Bai Lian AMPELOPSIS JAPONICA TUBER, Bai Zhi - ANGELICA DAHURICA ROOT, Dang Gui (ANGELICA SINENSIS ROOT), Chi Shao whole PAEONIA LACTIFLORA WHOLE, Qiang Huo whole (HANSENIA FORBESII WHOLE, Wu Yao - LINDERA AGGREGATA ROOT, Gan Cao (LICORICE), Du Huo (ANGELICA PUBESCENS ROOT), Xuan Shen (SCROPHULARIA NINGPOENSIS ROOT), Da Huang ( RHEUM OFFICINALE ROOT), Liu Zhi (SOLIDAGO VIRGAUREA FLOWERING TOP, Methyl salicylate


Advanced Ingredient Data


Raw Label Data

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