TIANHE GUTONG TIEGAO (IN POLYISOBUTYLENE CARRIER) - external analgesic patch patch 
GUILIN TIANHE PHARMACEUTICAL CO LTD

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.

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DRUG FACTS

Active ingredients
Camphor 4%
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:

Do not use

When using this product

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

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.

Other information

Inactive ingredients cinnamon oil, dong-quai root, erycibe (Erycibe
obtusifolia Benth.) stem, fragrant angelica root, frankincense oleo-gum-resin,
futokadsura [Kadsura heteroclita (Roxb.) Craib] stem, ginger rhizome, paraffin,
san-qi ginseng root, stephania (Stephania sinica Diels.) root, and turmeric
rhizome, in a polyisobutylene carrier covered with protective paper.

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

TIANHE GUTONG TIEGAO PAIN RELIEVING PATCH NDC 68007-202-01 4 PATCHES EACH PATCH 2.75 IN X 4 IN (7 CM X 10 CM)IMAGE OF CARTON

TIANHE GUTONG TIEGAO (IN POLYISOBUTYLENE CARRIER) 
external analgesic patch patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68007-202
Route of AdministrationTRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)4 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.25 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.05 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68007-202-014 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/FEIBusiness Operations
GUILIN TIANHE PHARMACEUTICAL CO LTD528565427manufacture

Revised: 5/2010
Document Id: fb358e32-8e4d-4041-8cf6-e07425c14706
Set id: d66f0e9f-c2b8-43e8-9814-c0661ae4bbff
Version: 1
Effective Time: 20100524
 
GUILIN TIANHE PHARMACEUTICAL CO LTD