PAIN RELIEF (LIDOCAINE HYDROCHLORIDE,MENTHOL,METHYL SALICYLATE) PATCH [ZHEJIANG DONGYANG YINDA BIOLOGY CO., LTD]

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  • PAIN RELIEF (LIDOCAINE HYDROCHLORIDE,MENTHOL,METHYL SALICYLATE) PATCH [ZHEJIANG DONGYANG YINDA BIOLOGY CO., LTD]

PAIN RELIEF (LIDOCAINE HYDROCHLORIDE,MENTHOL,METHYL SALICYLATE) PATCH [ZHEJIANG DONGYANG YINDA BIOLOGY CO., LTD]
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NDC 70355-001-09, 70355-001-10, 70355-001-11, 70355-001-12, 70355-001-13, 70355-001-14, 70355-001-15, 70355-001-16
Set ID 282b1b6c-2b48-5d91-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager ZHEJIANG DONGYANG YINDA BIOLOGY CO., LTD
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
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  • Active Ingredient

    Lidocaine 4% ………………………………………………………………………………………………Topical Anesthetic

    Menthol 5% …………………………………………………………………………………………… Topical Analgesic

    Methyl Salicylate 4% ………………………………………………………………………………… Topical Analgesic

  • Purpose

    Topical Anesthetic

  • Use

    Temporarily relieves aches and pains of muscles and joints associated

    with: ·arthritis ·simple backache ·sprains ·strains ·muscle soreness

  • WARNINGS

    Warnings

    For external use only

    Do not use ·on the face or rashes·on open wounds, cuts, damaged or infected skin ·with a heating pad ·if allergic to any ingredients · if condition worsens or symptoms persist for more than 7 days ·excessive skin irritation occurs

    Ask a doctor before use if: .you are allergic to any ingredients ·you have high blood pressure,heart disease,or kidney disease ·you are pregnant

    When using this product: avoid contact with eyes, genitals, and other mucus membranes. If eye contact occurs, rinse thoroughly with water.

    If pregnant or breast-feeding, ask a health professional before use.
  • 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.Package not child resistant.Dispose of the used patches by folding sticky ends together.

  • Directions

    Adults and children over 12years: ·Carefully remove protective film from patch ·Apply one patch to affected area ·Repeat as necessary,but no more than 4 times daily.

    Children under 12 years of age: Ask a doctor

  • Inactive Ingredients

    Inactive Ingredients:

    Acrulic Acid, Aluminum Hydroxide, Carmellose Sodium, 2-Ethylhexyl Acrylate, Glycerin, Isopropyl Myristate, Methyl Acrylate, Nonoxy-nol-30, Polyacrylic Acid, Polysorbate 80, Sodium Polyacrylate, Sorbitan Sesquioleate, Starch, Talc, Tartaric Acid, Titanium Diocide, Water

  • OTHER SAFETY INFORMATION

    Other information

    .some individuals may not experience pain relief until several minutes or hours after applying the patch

    avoid storing product in direct sunlight .protect product from excessive moisture .store at 67-77°F (19-25°C)

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF 
    lidocaine hydrochloride,menthol,methyl salicylate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70355-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE4 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TALC (UNII: 7SEV7J4R1U)  
    TARTARIC ACID (UNII: W4888I119H)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    ACRYLIC ACID (UNII: J94PBK7X8S)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYL ACRYLATE (UNII: WC487PR91H)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    NONOXYNOL-30 (UNII: JJX07DG188)  
    POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70355-001-0915 in 1 BOX
    13 in 1 POUCH
    10.408 g in 1 PATCH; Type 0: Not a Combination Product
    2NDC:70355-001-1015 in 1 BOX
    25 in 1 POUCH
    20.408 g in 1 PATCH; Type 0: Not a Combination Product
    3NDC:70355-001-116 in 1 BOX
    33 in 1 POUCH
    30.408 g in 1 PATCH; Type 0: Not a Combination Product
    4NDC:70355-001-124 in 1 BOX
    41 in 1 POUCH
    40.408 g in 1 PATCH; Type 0: Not a Combination Product
    5NDC:70355-001-1324 in 1 BOX
    52 in 1 POUCH
    50.85 g in 1 PATCH; Type 0: Not a Combination Product
    6NDC:70355-001-1424 in 1 BOX
    64 in 1 POUCH
    60.408 g in 1 PATCH; Type 0: Not a Combination Product
    7NDC:70355-001-1524 in 1 BOX
    75 in 1 POUCH
    70.408 g in 1 PATCH; Type 0: Not a Combination Product
    8NDC:70355-001-1624 in 1 BOX
    86 in 1 POUCH
    80.408 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/30/2015
    Labeler - ZHEJIANG DONGYANG YINDA BIOLOGY CO., LTD (546989657)
    Establishment
    NameAddressID/FEIBusiness Operations
    ZHEJIANG DONGYANG YINDA BIOLOGY CO., LTD546989657manufacture(70355-001)
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