NDC | 54494-001-01 |
Set ID | ece6cd1d-e063-454e-909e-5184796286da |
Category | HUMAN OTC DRUG LABEL |
Packager | SICHUAN EMEISHAN PHARMACEUTICAL CO., LTD. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART348 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
Uses
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For the temporary relief of minor aches and pains of muscles and joints due to:
■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains - WARNINGS
Warnings
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For external use only
Allergy alert: This product contains natural rubber latex which may cause allergic reactions - DO NOT USE
- WHEN USING
When using this product
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■ 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
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■ 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.
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If swallowed, get medical help or contact a Poison Control Center right away. - DOSAGE & ADMINISTRATION
Directions
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■ 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
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■ 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
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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?
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(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
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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 plasterProduct 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)