TIANHE GUTONG TIEGAO- external analgesic patch patch

TIANHE GUTONG TIEGAO by

Drug Labeling and Warnings

TIANHE GUTONG TIEGAO by is a Otc medication manufactured, distributed, or labeled by GUILIN TIANHE PHARMACEUTICAL CO LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Camphor 3.5%

Capsicum providing capsaicin 0.25%

Menthol 3.05%

PURPOSE

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

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

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 DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are

• using other medications
• if pregnant or nursing

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

INACTIVE INGREDIENT

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

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

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)

INGREDIENTS AND APPEARANCE

TIANHE GUTONG TIEGAO 
external analgesic patch patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68007-201
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	3.5 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.25 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3.05 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68007-201-01	10 in 1 BOX

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/24/2010

Labeler - GUILIN TIANHE PHARMACEUTICAL CO LTD (528565427)

Establishment
Name	Address	ID/FEI	Business Operations
GUILIN TIANHE PHARMACEUTICAL CO LTD		528565427	manufacture