TIANHE ZHUANGGU GAO- pain relieving plaster plaster

TIANHE ZHUANGGU GAO by

Drug Labeling and Warnings

TIANHE ZHUANGGU 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 3.22%
Menthol 1.39%
Methyl salicylate 15.01%

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 irritated or damaged skin
• on wounds
• with a heating pad
• if pregnant or nursing
• otherwise than as directed

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 to avoid accidental poisoning. 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.

• adults and children 12 years of age and older: apply one plaster to affected area not more than 3 to 4 times daily
• children under 12 years of age: do not use, consult your physician
• refer to the above warnings; use otherwise than as directed may be dangerous
  

STORAGE AND HANDLING

Other information

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

INACTIVE INGREDIENT

Inactive ingredients dong quai root, ginger rhizome, lanolin, paraffin,
petrolatum, rosin, 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 ZHANGGU GAO PAIN RELIEVING PLASTER NDC: 68007-203-01 10 PLASTERS EACH PLASTER 2.27 IN X 4 IN (7 CM X 10 CM)

INGREDIENTS AND APPEARANCE

TIANHE ZHUANGGU GAO 
pain relieving plaster plaster

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68007-203
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	3.22 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.39 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y)	METHYL SALICYLATE	15.01 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68007-203-01	10 in 1 BOX

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/25/2010

Labeler - GUILIN TIANHE PHARMACEUTICAL CO LTD (528565427)

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