Label: GUTONG TIEGAO PAIN RELIEVING- camphor and menthol patch

  • NDC Code(s): 68007-301-01
  • 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 July 11, 2018

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

  • ACTIVE INGREDIENT

    Active ingredients

    Camphor 3.1%

    Menthol 1.25%

  • 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

  • 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 are

    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. 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 8 to 30 C (46 to 86 F), away from sunlight

  • INACTIVE INGREDIENT

    Inactive ingredients

    aluminum hydroxide, capsicum, cinnamon oil, dong-quai root, erycibe (Erycibe obtusifolia Benth.) stem, fragrant angelica root, frankincense oleo-gum-resin, ginger rhizome, glycerin, kadsura pepper [Piper kadsura (Choisy) Ohwi] stem, kaolin, polyacrylic acid, san-qi ginseng root, stephania (Stephania sinica Diels.) root, titanium dioxide, turmeric rhizome, and water 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 Hydrogel Pain Relieving Patch

    NDC 68007-301-01

    6 Patches

    Each Patch 2.75 in x 4 in (7 cm x 10 cm)

    2 Patches Per Pouch
    IMAGE OF CARTON

  • INGREDIENTS AND APPEARANCE
    GUTONG TIEGAO PAIN RELIEVING 
    camphor and menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68007-301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)248 mg
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL100 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    CAPSICUM (UNII: 00UK7646FG)  
    CINNAMON OIL (UNII: E5GY4I6YCZ)  
    ANGELICA SINENSIS ROOT (UNII: B66F4574UG)  
    ERYCIBE OBTUSIFOLIA STEM (UNII: V1G1S38CQI)  
    ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    ZINGIBER OFFICINALE WHOLE (UNII: IN6Q3S3414)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PIPER KADSURA STEM (UNII: 80IOP41EL7)  
    KAOLIN (UNII: 24H4NWX5CO)  
    POLYACRYLIC ACID (800000 MW) (UNII: D0I6NSZ87U)  
    PANAX NOTOGINSENG ROOT (UNII: GQX1C1175U)  
    HUPERZIA SERRATA (UNII: TLA53E5A4T)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TURMERIC (UNII: 856YO1Z64F)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68007-301-013 in 1 BOX04/13/2016
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/13/2016
    Labeler - GUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD (528565427)
    Establishment
    NameAddressID/FEIBusiness Operations
    GUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD528565427relabel(68007-301)
    Establishment
    NameAddressID/FEIBusiness Operations
    FOSHAN AQUA GEL BIOTECH CO LTD529128763manufacture(68007-301)