Label: GUTONG TIEGAO PAIN RELIEVING- menthol plaster

  • NDC Code(s): 68007-400-01
  • Packager: GUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD
  • 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 10, 2021

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

  • Active Ingredients
    Menthol 3.5%

  • PURPOSE

    Purpose
    External Analgesic

  • INDICATIONS & USAGE

    Uses
    For the temporary relief of minor aches and pains of muscles and joints due to:
    ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains

  • WARNINGS

    Warnings
    For external use only

    Allergy alert: This product contains natural rubber latex which may cause allergic reactions.

  • 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 change

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you have
    ■ using other medications
    ■ if pregnant or nursing

  • 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

  • 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 to avoid accidental poisoning. 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 2 years of age and older: remove the protective film from the plaster. Apply to affected area not more than 3 to 4 times daily.
    ■ children under 2 years of age: consult your physician.

  • STORAGE AND HANDLING

    Other information
    ■ keep tightly sealed
    ■ store at 8 to 30 C (46 to 86 F), away from sunlight

  • INACTIVE INGREDIENT

    Inactive ingredients angelica sinensis root, cinnamon oil, erycibe (Erycibe obtusifolia Benth.) stem, fragrant angelica root, frankincense oleo-gum-resin, ginger rhizome, kadsura pepper [Piper kadsura (Choisy) Ohwi] stem, lanolin, paprika, petrolatum, rosin, rubber, san-qi ginseng root, stephania (Stephania sinica Diels.) root, styrene-isoprene, turmeric rhizome, and zinc oxide on a fabric backing covered with protective paper film.

  • 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

    Gutong Tiegao Pain Relieving Plaster


    NDC 68007-400-01


    10 Patches
    Each Patch 2.75 in x 4 in (7 cm x 10 cm)
    5 Patches per Pouch

    IMAGE OF BOX

  • INGREDIENTS AND APPEARANCE
    GUTONG TIEGAO PAIN RELIEVING 
    menthol plaster
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68007-400
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL35 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANGELICA SINENSIS ROOT (UNII: B66F4574UG)  
    CINNAMON OIL (UNII: E5GY4I6YCZ)  
    ERYCIBE OBTUSIFOLIA STEM (UNII: V1G1S38CQI)  
    ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    GINGER (UNII: C5529G5JPQ)  
    PIPER KADSURA STEM (UNII: 80IOP41EL7)  
    LANOLIN (UNII: 7EV65EAW6H)  
    PAPRIKA (UNII: X72Z47861V)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ROSIN (UNII: 88S87KL877)  
    NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
    PANAX NOTOGINSENG ROOT (UNII: GQX1C1175U)  
    STEPHANIA SINICA WHOLE (UNII: 529T7EWP3I)  
    STYRENE (UNII: 44LJ2U959V)  
    ISOPRENE (UNII: 0A62964IBU)  
    TURMERIC (UNII: 856YO1Z64F)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68007-400-012 in 1 BOX05/10/2021
    15 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/10/2021
    Labeler - GUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD (528565427)
    Establishment
    NameAddressID/FEIBusiness Operations
    GUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD528565427manufacture(68007-400)