SHANG SHI ZHI TONG GAO- camphor, menthol, methyl salicylate plaster 
Henan Lingrui 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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Henan Lingrui Pharmaceutical Co.; Ltd

ACTIVE INGREDIENTS

Camphor 3.0%

Menthol 1.5%

Methyl Salicylate 2.5%

PURPOSE

Camphor   External Analgesic

Menthol     External Analgesic

Methyl Salicylate   External Analgesic

USES

To relieve the rheumatic pain and arthralgia by promoting blood circulation, used for rheumatoid arthristis muscular aches, sprain etc.

WARNINGS

For external use only.

Agergy Alert: This product contains natural rubber latex which may cause allergic reactions.

DO NOT USE

Do not use

on wounds.

on irritated or damaged skin

if the apperance of this product has changed

in excess of 12 hours

if you have know hypersensitivities to this product

otherwise than as directed

Ask a Doctor or Pharmacist before use if you are

Pregnent

taking other medications

When using this product

avoid contact iwth the eyes or mucous membrances

do not bandage tightly

supervise use by children

use caution if prone to allergic reactions

Stop use and ask a doctor if

condition worsens

symptonms persist for more than 7 days

symptoms clear up and occur again within 1 few days

excessive irritation of the skin develops

when using for pain of arthritis

pain persists for more than 10 days

redness is present

in conditions affecting children under 12 years

Keep out of reach of children.

Keep out of reach of children. If swallowed, get medical help or Poison Control Center right away.

Adults and children 12 years of age and older: Apply one or two plasters to affected area once a day. Remove after 12 hours.
DIRECTIONB
Refer to the above warnings: use otherwise than as directed may be dangerous.

Adults and children 12 years of age and older: Apply one or two plasters to affected area once a day. Remove after 12 hours.
Children 2 to 12 years of age and adults with compromised health: Use only under the guidance of a doctor.
Children under 2 years of age: Do not use, consult a doctor.
Refer to the above warnings: use otherwise than as directed may be dangerous.

OTHER INFORMATION

Keep container tightly closed.

Store below 20 degree centigrade (68 E F) in a dry area.

INACTIVE INGREDIENTS

BOSWELLIA SACRA BARK, COMMIPHORA MYRRHA TOP, CLOVE, CINNAMOMUM AROMATICUM WHOLE, SCHIZONEPETA TENUIFOLIA WHOLE, SAPOSHNIKOVIA DIVARICATA ROOT, GERANIUM WILFORDII TOP, PERIPLOCA SEPIUM ROOT BARK, DRYNARIA FORTUNEI ROOT, ANGELICA DAHURICA ROOT, GINGER, BORNEOL, BELLADONNA LEAF, NATURAL LATEX RUBBER, ROSIN, ZINC OXIDE, LANOLIN, PARAFFIN, DIMETHYL SULFOXIDE, ANTIOXIDANT 119

Questions or Commnets?

E-mail: info@bjwellspring.com

DRUG FACTS

image description

SHANG SHI ZHI TONG GAO 
camphor, menthol, methyl salicylate plaster
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42217-201
Route of AdministrationTRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)3.0 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.5 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE2.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BOSWELLIA SACRA BARK (UNII: 1UK28DX728)  
COMMIPHORA MYRRHA TOP (UNII: N534J96ODY)  
CLOVE (UNII: K48IKT5321)  
CINNAMOMUM AROMATICUM WHOLE (UNII: 9BPF21T8ZR)  
SCHIZONEPETA TENUIFOLIA WHOLE (UNII: C1107616TR)  
SAPOSHNIKOVIA DIVARICATA ROOT (UNII: 8H84LFK2QD)  
GERANIUM WILFORDII TOP (UNII: 771B1S9W3R)  
PERIPLOCA SEPIUM ROOT BARK (UNII: 638OW484M3)  
DRYNARIA FORTUNEI ROOT (UNII: 731W842X8Q)  
ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)  
GINGER (UNII: C5529G5JPQ)  
BORNEOL (UNII: M89NIB437X)  
BELLADONNA LEAF (UNII: 6GZW20TIOI)  
NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
ROSIN (UNII: 88S87KL877)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
LANOLIN (UNII: 7EV65EAW6H)  
PARAFFIN (UNII: I9O0E3H2ZE)  
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
ANTIOXIDANT 119 (UNII: UBL01213LI)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42217-201-1010 in 1 BOX
11 g in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/02/2010
Labeler - Henan Lingrui Pharmaceutical Co.; Ltd (530021062)
Registrant - Henan Lingrui Pharmaceutical Co.; Ltd (530021062)
Establishment
NameAddressID/FEIBusiness Operations
Henan Lingrui Pharmaceutical Co.; Ltd530021062manufacture(42217-201)

Revised: 2/2014
Document Id: 23666d8f-e4f9-4331-b50e-78c86bb9efd4
Set id: 2d61c9b9-587d-4406-bbdb-2c627cdef02f
Version: 3021
Effective Time: 20140227
 
Henan Lingrui Pharmaceutical Co.; Ltd