FDA Label for E Mei Shan Medicated

The following document was submitted to the FDA by the labeler of this product Sichuan Emeishan Pharmaceutical Co., Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient

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

Otc - 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

Otc - Do Not Use

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

Otc - 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

Otc - 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

Otc - 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 15° to 30° C (59° to 86° 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.

Otc - 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

Package Label.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)

PRINCIPAL DISPLAY PANEL - box1

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