GUTONG TIEGAO PAIN RELIEVING- menthol plaster 
GUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD

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.

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Drug Facts

Active Ingredients
Menthol 3.5%

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

Warnings
For external use only

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

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

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 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 to avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center right away.

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.

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

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 or comments?
(888) 221-3496 M-F 9 am to 5 pm
■ you may also report serious side effects to this phone number

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

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)

Revised: 5/2021
Document Id: b1abe042-4a8d-4d52-8aed-ccee346e84c2
Set id: 5a5c3759-90e0-4a93-99cf-ddbf00aba10d
Version: 2
Effective Time: 20210510
 
GUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD