E MEI SHAN MEDICATED- camphor, menthol, methyl salicylate plaster 
SICHUAN EMEISHAN 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 3.1%
Menthol 2.6%
Methyl Salicylate 10.1%

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

Warnings
For external use only
Allergy alert: This product contains natural rubber latex which may cause allergic reactions

Do not use
■ on irritated or damaged skin ■ on wounds ■ otherwise than as directed

When using this product
■ avoid contact with the eyes or mucous membranes
■ do not bandage tightly
■ avoid placing on extremely hairy areas of skin to avoid irritation upon removing the plaster

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 to avoid accidental poisoning.
If swallowed, get medical help or contact a Poison Control Center right away.

Directions
■ adults and children 3 years of age and older: remove the protective film from the plaster. Apply to affected area not more than 3 to 4 times daily.
■ children under 3 years of age: consult your physician
■ refer to the above warnings; use otherwise than as directed may be dangerous

Other information
■ keep plasters tightly closed in the zip-lock pouch
■ store at 15º to 30º C (59º to 86º F) in a dry place away from sunlight

Inactive ingredients
Dong quai root, fragrant angelica root, ginger, lanolin, mineral oil, natural latex rubber, petrolatum, rosin, zinc oxide, star anise fruit, and antioxidant 1010.

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
EXTERNAL ANALGESIC
NDC 54494-001-01
E MEI SHAN MEDICATED PLASTER
■ Simple backache ■ Arthritis ■ Strains ■ Bruises ■ Sprains
5 PLASTERS
Each plaster 7 x 10 cm (2.76 x 3.94 Inches)
PRINCIPAL DISPLAY PANEL

E MEI SHAN MEDICATED 
camphor, menthol, methyl salicylate plaster
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54494-001
Route of AdministrationTRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)36 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL30 mg
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE119 mg
Inactive Ingredients
Ingredient NameStrength
ANGELICA SINENSIS ROOT (UNII: B66F4574UG)  
ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)  
GINGER (UNII: C5529G5JPQ)  
LANOLIN (UNII: 7EV65EAW6H)  
MINERAL OIL (UNII: T5L8T28FGP)  
NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
PETROLATUM (UNII: 4T6H12BN9U)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
ROSIN (UNII: 88S87KL877)  
STAR ANISE FRUIT (UNII: CK15HA8438)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54494-001-011 in 1 BOX02/19/2013
15 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/19/2013
Labeler - SICHUAN EMEISHAN PHARMACEUTICAL CO., LTD. (529114359)
Registrant - SICHUAN EMEISHAN PHARMACEUTICAL CO., LTD. (529114359)
Establishment
NameAddressID/FEIBusiness Operations
SICHUAN EMEISHAN PHARMACEUTICAL CO., LTD.529114359manufacture(54494-001)

Revised: 8/2017
Document Id: 72a3c003-7900-4f08-9d37-e0ad241975df
Set id: ece6cd1d-e063-454e-909e-5184796286da
Version: 4
Effective Time: 20170811
 
SICHUAN EMEISHAN PHARMACEUTICAL CO., LTD.