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
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- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- ASK DOCTOR/PHARMACIST
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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
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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
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GUTONG TIEGAO PAIN RELIEVING
menthol plasterProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68007-400 Route of Administration TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 35 mg Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:68007-400-01 2 in 1 BOX 05/10/2021 1 5 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 05/10/2021 Labeler - GUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD (528565427) Establishment Name Address ID/FEI Business Operations GUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD 528565427 manufacture(68007-400)