E MEI SHAN MEDICATED- camphor, menthol, methyl salicylate plaster

E MEI SHAN MEDICATED by

Drug Labeling and Warnings

E MEI SHAN MEDICATED by is a Otc medication manufactured, distributed, or labeled by SICHUAN EMEISHAN PHARMACEUTICAL CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients
Camphor 3.1%
Menthol 2.6%
Methyl Salicylate 10.1%

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 irritated or damaged skin ■ on wounds ■ otherwise than as directed

WHEN USING

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

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: 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

STORAGE AND HANDLING

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 INGREDIENT

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

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

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)

INGREDIENTS AND APPEARANCE

E MEI SHAN MEDICATED 
camphor, menthol, methyl salicylate plaster

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54494-001
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	36 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	30 mg
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	119 mg

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54494-001-01	1 in 1 BOX	02/19/2013
1		5 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	02/19/2013

Labeler - SICHUAN EMEISHAN PHARMACEUTICAL CO., LTD. (529114359)

Registrant - SICHUAN EMEISHAN PHARMACEUTICAL CO., LTD. (529114359)

Establishment
Name	Address	ID/FEI	Business Operations
SICHUAN EMEISHAN PHARMACEUTICAL CO., LTD.		529114359	manufacture(54494-001)