Label: HUA TUO MEDICATED PLASTER EXTRA STRENGTH- menthol camphor patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 31, 2019

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Menthol 3%
    Camphor10%

  • 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 68-77ºF (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

  • INGREDIENTS AND APPEARANCE
    HUA TUO  MEDICATED PLASTER EXTRA STRENGTH
    menthol camphor patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61821-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)10 g
    Inactive Ingredients
    Ingredient NameStrength
    ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)  
    ANGELICA PUBESCENS ROOT (UNII: 0MF1EI01KJ)  
    BOSWELLIA SACRA WHOLE (UNII: 8O600AZL0W)  
    CARTHAMUS TINCTORIUS FLOWER BUD (UNII: B86IS274O0)  
    CINNAMON OIL (UNII: E5GY4I6YCZ)  
    CLOVE OIL (UNII: 578389D6D0)  
    COMMIPHORA AFRICANA RESIN (UNII: W30OSW7A0S)  
    DRYNARIA FORTUNEI ROOT (UNII: 731W842X8Q)  
    ELEUTHEROCOCCUS NODIFLORUS ROOT BARK (UNII: W7PRK433YB)  
    GINGER (UNII: C5529G5JPQ)  
    GLECHOMA LONGITUBA WHOLE (UNII: 79GOE5902E)  
    PANAX NOTOGINSENG ROOT (UNII: GQX1C1175U)  
    SAPOSHNIKOVIA DIVARICATA ROOT (UNII: 8H84LFK2QD)  
    NEPETA TENUIFOLIA FLOWERING TOP (UNII: 2FN3BA1MZE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61821-100-055 in 1 BOX; Type 0: Not a Combination Product05/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/01/2014
    Labeler - GUANGZHOU BAIYUNSHAN JINGXIUTANG PHARMACEUTICAL COMPANY (654032218)
    Establishment
    NameAddressID/FEIBusiness Operations
    GUANGZHOU BAIYUNSHAN JINGXIUTANG PHARMACEUTICAL COMPANY654032218manufacture(61821-100)