Otc - Active Ingredient
Active Ingredients
Camphor 3.1%
Menthol 2.6%
Methyl Salicylate 10.1%
E Mei Shan Medicated
FDA Label NDC 54494-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sichuan Emeishan Pharmaceutical Co., Ltd. for the product E Mei Shan Medicated (NDC 54494-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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)
* Please review the disclaimer below.
