Wen Tong Gao Ointment
FDA Label NDC 85954-003

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cai Industries Corp. for the product Wen Tong Gao (NDC 85954-003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, directions, other information, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Menthol 15%

Purpose

External analgesic

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

Other Information

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

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

Product Label

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