SHANGHAI SHANG SHI ZHI TONG GAO PAIN RELIEVING- camphor, menthol, methyl salicylate patch

SHANGHAI SHANG SHI ZHI TONG GAO PAIN RELIEVING by

Drug Labeling and Warnings

SHANGHAI SHANG SHI ZHI TONG GAO PAIN RELIEVING by is a Otc medication manufactured, distributed, or labeled by SHANGHAI LEI YUN SHANG PHARMACEUTICAL CO LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients
Camphor 10%
Menthol 10.28%
Methyl salicylate 15.43%

PURPOSE

Purpose
External analgesic

INDICATIONS & USAGE

Uses
For the temporary relief of minor aches and pains of muscles and joints due to:
simple backache
arthritis
strains
bruises
sprains

WARNINGS

Warnings
For external use only

Allergy 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 pregnant
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
adults and children 3 years of age and older: clean and dry the skin and apply the patch to the affected area not than 3 to 4 times daily. Each patch is effective for 2-3 days.
children under 3 years of age: consult your physician.
refer to the above warnings; use otherwise than as directed may be dangerous.

STORAGE AND HANDLING

Other information
for unused patches remaining in the pouch, re-seal securely
store at room temperature

INACTIVE INGREDIENT

Inactive ingredientsCinnamon, clove extract, drynaria root and stem, fang feng root, fragrant angelica root, frankincense resin, geranium (Geranium wilfordii Maxim) stem, leaf, and fruit, glycerol ester of rosin gum, gotu kola herb, greater galangal root and stem, kaolin, lanolin, lithopone (mixture of barium sulfate, zinc sulfide, and trace zinc oxide), mineral oil, myrrh, oriental sweet gum (Liquidambar orientalis Mill.) resin, paraffin, periploca sepium (Periploca sepium Bunge) bark, petrolatum, schizonepeta [Schizonepeta tenuifolia (Benth.) Briq.] stem and leaf, on a rubberized fabric backing covered with a protective paper sheet.

QUESTIONS

Questions or comments? (888) 221-3496 M-F 9 am to 5 pm
you may also report serious side effects to thi phone number

PRINCIPAL DISPLAY PANEL

SHANGHAI SHANG SHI ZHI TONG GAO

Pain Relieving Patch

External Analgesic

NDC: 22742-003-01

6 Patches in 3 Pouches Each Patch 2.75 in x 3.94 in (7 cm x 10 cm)

INGREDIENTS AND APPEARANCE

SHANGHAI SHANG SHI ZHI TONG GAO PAIN RELIEVING 
camphor, menthol, methyl salicylate patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 22742-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	10
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10.28
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	15.43

Inactive Ingredients
Ingredient Name	Strength
CINNAMON (UNII: 5S29HWU6QB)
CLOVE (UNII: K48IKT5321)
DRYNARIA FORTUNEI ROOT (UNII: 731W842X8Q)
SAPOSHNIKOVIA DIVARICATA ROOT (UNII: 8H84LFK2QD)
ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)
FRANKINCENSE (UNII: R9XLF1R1WM)
GERANIUM WILFORDII WHOLE (UNII: QXI974Y72W)
ROSIN PARTIALLY DIMERIZED GLYCEROL ESTER (UNII: BY866DXY67)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
ALPINIA GALANGA WHOLE (UNII: 3S1W839C0O)
KAOLIN (UNII: 24H4NWX5CO)
LANOLIN (UNII: 7EV65EAW6H)
BARIUM SULFATE (UNII: 25BB7EKE2E)
ZINC SULFIDE (UNII: KPS085631O)
ZINC OXIDE (UNII: SOI2LOH54Z)
MINERAL OIL (UNII: T5L8T28FGP)
MYRRH (UNII: JC71GJ1F3L)
LIQUIDAMBAR ORIENTALIS WHOLE (UNII: 759QNU787E)
PARAFFIN (UNII: I9O0E3H2ZE)
PERIPLOCA SEPIUM ROOT BARK (UNII: 638OW484M3)
PETROLATUM (UNII: 4T6H12BN9U)
SCHIZONEPETA TENUIFOLIA WHOLE (UNII: C1107616TR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 22742-003-01	3 in 1 BOX	03/09/2009
1		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/09/2009

Labeler - SHANGHAI LEI YUN SHANG PHARMACEUTICAL CO LTD (420978637)

Registrant - SHANGHAI LEI YUN SHANG PHARMACEUTICAL CO LTD (420978637)

Establishment
Name	Address	ID/FEI	Business Operations
SHANGHAI LEI YUN SHANG PHARMACEUTICAL CO LTD		420978637	manufacture(22742-003)