TIANHE GUBEN YAOSHEN TIE GAO- menthol patch

TIANHE GUBEN YAOSHEN TIE GAO by

Drug Labeling and Warnings

TIANHE GUBEN YAOSHEN TIE 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 Ingredient

Menthol 3%

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 and 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:
• • if pain persists for more than 10 days
    
  • if 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.

• adults and children 2 years of age and older: Apply patch to affected area not more than 3 to 4 times daily.
• children under 2 years of age: Do not use, consult a doctor.
  

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  achyranthes root, clove flower bud, mature deer
antler, mature fennel fruit, and scurfy-pea seed 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 GUBEN YAOSHEN TIE PAIN RELIEVING PATCH NDC: 68007-200-01 8 PATCHES 2.75 IN X 4 IN (7 CM X 10 CM)

INGREDIENTS AND APPEARANCE

TIANHE GUBEN YAOSHEN TIE GAO 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68007-200
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68007-200-01	8 in 1 BOX

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/26/2010

Labeler - GUILIN TIANHE PHARMACEUTICAL CO LTD (528565427)

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