NDC | 69070-300-01 |
Set ID | bda1e7c1-42df-4126-a512-80f843b07fd0 |
Category | HUMAN OTC DRUG LABEL |
Packager | Zhejiang Dingtai 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
For external use onlyAllergy alert: This product contains natural rubber latex which may cause allergic reactions
Report any unexpected side effects from the use of this product to the FDA MedWatch Program
Close - DO NOT USE
- ASK DOCTOR/PHARMACIST
- WHEN USING
When using this product
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■ avoid contact with the eyes or mucous membranes
■ do not bandage tightly
■ do not apply heat to the area in the form of heating pads, hot water bottles, or lamps (doing so increases the risk of serious burns)
■ 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
■ you feel actual pain or experience blistering or burning after application (it is normal to feel a warming or cooling sensation)
■ 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. If swallowed, get medical help or contact a Poison Control Center right away.
Close - DOSAGE & ADMINISTRATION
Directions
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■ adults and children 2 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 2 years of age: consult your physician - 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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Butylated hydroxytoluene, dong quai root, fragrant angelica root, ginger root, lanolin, light mineral oil, natural latex rubber, petrolatum, rosin, star anise fruit, and zinc oxide on a cotton pad - 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
E MEI SHAN MEDICATED PLASTER
NDC 69070-300-01
Simple backache, Arthritis, Strains, Bruises, Sprains
5 Plaster
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Each Plaster 7 x 10 cm (2.76 x 3.94 in) - INGREDIENTS AND APPEARANCE
E MEI SHAN MEDICATED
camphor, menthol plasterProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69070-300 Route of Administration TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 31 mg MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 26 mg Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ANGELICA SINENSIS ROOT (UNII: B66F4574UG) ANGELICA DAHURICA ROOT (UNII: 1V63N2S972) GINGER (UNII: C5529G5JPQ) LANOLIN (UNII: 7EV65EAW6H) LIGHT MINERAL OIL (UNII: N6K5787QVP) NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN) PETROLATUM (UNII: 4T6H12BN9U) ROSIN (UNII: 88S87KL877) STAR ANISE (UNII: XKC1657P78) ZINC OXIDE (UNII: SOI2LOH54Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69070-300-01 1 in 1 BOX 09/17/2018 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 09/17/2018 Labeler - Zhejiang Dingtai Pharmaceutical Co., Ltd (420598724) Establishment Name Address ID/FEI Business Operations Zhejiang Dingtai Pharmaceutical Co., Ltd 420598724 manufacture(69070-300)