TIANHE GUTONG TIEGAO

Dosage form: patch
Ingredients: CAMPHOR (NATURAL) 3.5g, CAPSAICIN 0.25g, MENTHOL 3.05g
Labeler: GUILIN TIANHE PHARMACEUTICAL CO LTD
NDC Code: 68007-201

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 FACTS

Active ingredients

Camphor 3.5%

Capsicum providing capsaicin 0.25%

Menthol 3.05%

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

  • 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 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 a doctor or pharmacist before use if you are

  • using other medications
  • if pregnant or nursing

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. 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 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.

Other information

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

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 or comments? (888) 221-3496 M-F 9 am to 5 pm

  • you may also report serious side effects to this phone number

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)
TIANHE GUTONG TIEGAO 
external analgesic patch patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68007-201
Route of AdministrationTRANSDERMALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (NATURAL) (CAMPHOR (NATURAL)) CAMPHOR (NATURAL)3.5 g
CAPSAICIN (CAPSAICIN) CAPSAICIN0.25 g
MENTHOL (MENTHOL) MENTHOL3.05 g
Packaging
#Item CodePackage Description
1NDC:68007-201-0110 PATCH (PATCH) 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/FEIOperations
GUILIN TIANHE PHARMACEUTICAL CO LTD528565427manufacture

Revised: 05/2010
 
GUILIN TIANHE PHARMACEUTICAL CO LTD

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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