Label: TIANHE GUBEN YAOSHEN TIE GAO- menthol 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 April 26, 2010

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  • ACTIVE INGREDIENT

    Active Ingredient

    Menthol 3%

  • 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 and 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:
      • if pain persists for more than 10 days
      • if 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 patch.

    • adults and children 2 years of age and older: Apply patch to affected area not more than 3 to 4 times daily.
    • children under 2 years of age: Do not use, consult a doctor.
  • STORAGE AND HANDLING

    Other Information

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

    Inactive Ingredients  achyranthes root, clove flower bud, mature deer
    antler, mature fennel fruit, and scurfy-pea seed 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 GUBEN YAOSHEN TIE PAIN RELIEVING PATCH NDC 68007-200-01 8 PATCHES 2.75 IN X 4 IN (7 CM X 10 CM)
    IMAGE OF CARTON
  • INGREDIENTS AND APPEARANCE
    TIANHE GUBEN YAOSHEN TIE GAO 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68007-200
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68007-200-018 in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/26/2010
    Labeler - GUILIN TIANHE PHARMACEUTICAL CO LTD (528565427)
    Establishment
    NameAddressID/FEIBusiness Operations
    GUILIN TIANHE PHARMACEUTICAL CO LTD528565427manufacture
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