OTC Medication Information: E MEI SHAN MEDICATED

E MEI SHAN MEDICATED- camphor (synthetic), menthol and 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.

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
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC) 36 mg
MENTHOL (MENTHOL) MENTHOL 30 mg
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 119 mg
Inactive Ingredients
Ingredient Name Strength
ANGELICA SINENSIS ROOT
ANGELICA DAHURICA ROOT
GINGER
LANOLIN
MINERAL OIL
NATURAL LATEX RUBBER
PETROLATUM
ZINC OXIDE
ROSIN
STAR ANISE FRUIT
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54494-001-01 1 POUCH in 1 BOX contains a POUCH
1 5 PLASTER in 1 POUCH This package is contained within the BOX (54494-001-01)
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 Operations
SICHUAN EMEISHAN PHARMACEUTICAL CO., LTD. 529114359 manufacture (54494-001)

Revised: 08/2017 SICHUAN EMEISHAN PHARMACEUTICAL CO., LTD.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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