Label: TIANHE ZHUIFENG GAO- camphor, capsaicin and menthol plaster

  • 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 May 27, 2010

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  • ACTIVE INGREDIENT

    Active ingredients
    Camphor 4.75%
    Capsicum providing capsaicin 0.25%
    Menthol 1.4%

  • PURPOSE

    Purpose

    External Analgesic

    Uses  For the temporary relief of minor aches and pains of muscles and joints
    due to:

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • DO NOT USE

    Do not use

    • on wounds
    • on irritated or damaged skin
  • WHEN USING

    When using this product

    • avoid contact with the eyes or mucous membranes
    • do not bandage tightly
  • STOP USE

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
    • excessive irritation of the skin develops
    • nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs
    • when using for pain of arthritis:
      • pain persists for more than 10 days
      • redness is present
      • in conditions affecting children under 12 years of age
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a
    Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions Clean the affected area. Remove the paper film from the plaster and place the plaster on the affected area.

    • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
    • children under 2 years of age: do not use, consult your physician.
  • STORAGE AND HANDLING

    Other information

    • keep tightly sealed
    • store at room temperature 15º to 30º C (59º to 86º F)
  • INACTIVE INGREDIENT

    Inactive ingredients cinnamon oil, dong-quai root, dragon’s blood resin,
    frankincense oleo-gum-resin, lanolin, paraffin, petrolatum, pubescent angelica
    root, safflower flowers, rosin, and zinc oxide, on a rubber backing covered with
    protective paper.

  • QUESTIONS

    Questions or comments? (888) 221-3496 M-F 9 am to 5 pm

    •  you may also report serious side effects to this phone number
  • PRINCIPAL DISPLAY PANEL

    TIANHE ZHUIFENG GAO PAIN RELIEVING PLASTER NDC 68007-204-01 10 PLASTERS EACH PLASTER 2.75 IN X 4 IN (7 CM X 10 CM)IMAGE OF CARTON

  • INGREDIENTS AND APPEARANCE
    TIANHE ZHUIFENG GAO 
    camphor, capsaicin and menthol plaster
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68007-204
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)4.75 g
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.25 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.4 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68007-204-0110 in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/27/2010
    Labeler - GUILIN TIANHE PHARMACEUTICAL CO LTD (528565427)
    Establishment
    NameAddressID/FEIBusiness Operations
    GUILIN TIANHE PHARMACEUTICAL CO LTD528565427manufacture
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