TIANHE ZHUIFENG GAO- camphor, capsaicin and menthol plaster

TIANHE ZHUIFENG GAO by

Drug Labeling and Warnings

TIANHE ZHUIFENG GAO 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 4.75%
Capsicum providing capsaicin 0.25%
Menthol 1.4%

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 irritated or damaged skin
  

WHEN USING

When using this product

• avoid contact with the eyes or mucous membranes
• do not bandage tightly
  

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 plaster and place the plaster on the affected area.

• adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
• children under 2 years of age: do not use, consult your physician.
  

STORAGE AND HANDLING

Other information

• keep tightly sealed
• store at room temperature 15º to 30º C (59º to 86º F)

INACTIVE INGREDIENT

Inactive ingredients cinnamon oil, dong-quai root, dragon’s blood resin,
frankincense oleo-gum-resin, lanolin, paraffin, petrolatum, pubescent angelica
root, safflower flowers, rosin, and zinc oxide, on a rubber 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 ZHUIFENG GAO PAIN RELIEVING PLASTER NDC: 68007-204-01 10 PLASTERS EACH PLASTER 2.75 IN X 4 IN (7 CM X 10 CM)

INGREDIENTS AND APPEARANCE

TIANHE ZHUIFENG GAO 
camphor, capsaicin and menthol plaster

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68007-204
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	4.75 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.25 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.4 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68007-204-01	10 in 1 BOX

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/27/2010

Labeler - GUILIN TIANHE PHARMACEUTICAL CO LTD (528565427)

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