Label: TIANHE GUTONG TIEGAO- external analgesic patch 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 May 24, 2010

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

  • ACTIVE INGREDIENT

    Active ingredients

    Camphor 3.5%

    Capsicum providing capsaicin 0.25%

    Menthol 3.05%

  • 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 large parts of the body for extended periods of time
    • on irritated or damaged skin
    • if properties of this product changes
  • WHEN USING

    When using this product
    • avoid contact with the eyes or mucous membranes
    • do not bandage tightly
    • supervise use by children
    • use caution if prone to allergies
    • check carefully for hypersensitivity (skin reactions)
    • avoid placing on extremely hairy areas of skin to avoid irritation upon removing the patch
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

    • using other medications
    • if pregnant or nursing
  • 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 patch,and place the patch on the affected area, so that the direction of stretch is consistent with joint action.

    • adults and children 8 years of age and older: apply to affected area not more than 3 to 4 times daily. Do not use this product for longer than 8 hours in one day.
    • children under 8 years of age: do not use, consult your physician.
  • STORAGE AND HANDLING

    Other information

    • keep tightly sealed
    • store at 8º to 30º C (46º to 86º F), away from sunlight
  • INACTIVE INGREDIENT

    Inactive ingredients  dong-quai root, erycibe (Erycibe obtusifolia Benth.)
    stem, fragrant angelica root, frankincense oleo-gum-resin, ginger rhizome,
    futokadsura [Kadsura heteroclita (Roxb.) Craib] stem, lanolin, paraffin,
    petrolatum, rosin, san-qi ginseng root, stephania (Stephania sinica Diels.) root,
    and zinc oxide, on a rubberized fabric 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 GUTONG TIEGAO PAIN RELIEVING PATCH NDC 68007-201-01 10 PATCHES EACH PATCH 2.75 IN X 4 IN (7 CM X 10 CM)
    IMAGE OF CARTON
  • INGREDIENTS AND APPEARANCE
    TIANHE GUTONG TIEGAO 
    external analgesic patch patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68007-201
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)3.5 g
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.25 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.05 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68007-201-0110 in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/24/2010
    Labeler - GUILIN TIANHE PHARMACEUTICAL CO LTD (528565427)
    Establishment
    NameAddressID/FEIBusiness Operations
    GUILIN TIANHE PHARMACEUTICAL CO LTD528565427manufacture