Active Ingredients
Menthol 3%
Camphor10%
Hua Tuo
FDA Label NDC 61821-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Baiyunshan Jingxiutang Pharmaceutical Company for the product Hua Tuo (NDC 61821-100). 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, when using this product, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
External Analgesic
External Analgesic
Uses
For the temporary relief of minor pains and aches of muscles and joints associated with ■ simple backache ■ arthritis ■ strains ■ bruises
■ sprains
Warnings
For external use only ■ Do not use ■ do not apply to wounds or damaged skin
■ discontinue use if excessive irritation of the skin develops ■ condition affect children uner 12 years of age
When Using This Product
■ Avoid contact with the eyes or mucus membranes ■ do not bandage tightly ■ Do not use otherwise than as directed
Stop Use And Ask A Doctor If
■ condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
■ redness is present
Keep Out Of Reach Of Children
In case of accidental ingestion, contact a doctor or Poison Control Center immediately
Directions
■ Adults and children 12 years of age and older remove the clear film backing and apply to affected area not more than 3 to 4 times daily
■ Children under 12 years of age, consult a doctor before using.
■ Use caution when applying to hairy skin areas, highly adhesive plaster can hurt when removing.
Other Information
■ Store at 68-77F (20-25C)
Inactive Ingredients
angelica dahurica root, angelica pubescens root, boswellia sacra whole, carthamus tinctorius flower, cinnamon oil, clove oil, commiphora africana resin, drynaria fortunei root, eleutherococcus nodiflorus root bark, ginger, glechoma longituba whole, panax notoginseng root, saposhnikovia divaricata root, schizonepeta tenuifolia flowering top
Package Label
Image Description (Huatuoptchextanlgsc)
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