Label: ALIVIO MEDICATED PAIN- menthol, capsaicin patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 21, 2015

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  • Drug Facts

  • Active ingredient

    Menthol 5.00%

    Capsacin 0.03%

    Purpose

    External Analgesic

    External Analgesic

  • Uses:

    For temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

  • Warnings:

    • For external use only.
    • Avoid contact with eyes.

    Do not

    • apply to open wounds or damages skin.
    • bandage tightly
    • If symptoms persist for more than seven days, discontinue use and consult physician.

    Keep out of reach of children

    If swallwed, consult physician.

    If pregnant or breast feeding,

    contact physician prior to use.

  • Directions:

    • Clean and dry affected area.
    • Remove patch from backing and apply to affected area.  Apply directly to effected area.
    • Use only on patch at a time, and a maximum of four patches per day.
    • Leave patch on affected area for up eight hours.
    • Do not use patches for more than five consecutive days.
    • Children under 12 should consult a physician prior to use.
  • Other Ingredients:

    acrylic acid ,aluminum hydroxide .carmellose sodium 2-ethylhexyl acrylate .glycerin . isopropyl myristate .methyl acrylate

    nonoxynol-30 .polyacrylate.polyacrylic acid .polysorbate 80 sorbitan sesquioleate starch .talc .tartaric acid. titanium dioxide. water (245-114)

  • Store

    at room temperature.  Avoid direct sunlight

  • Package Label

    Alivio Patch

    MEDICATED PAIN PATCH

    15 PATCHES

    Distributed by:

    Alivio Medical Products

    Hollywood, FL 33020

    AlivioPatch2

  • INGREDIENTS AND APPEARANCE
    ALIVIO MEDICATED PAIN 
    menthol, capsaicin patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69512-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 g
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN.03 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ACRYLIC ACID (UNII: J94PBK7X8S)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYL ACRYLATE (UNII: WC487PR91H)  
    NONOXYNOL-30 (UNII: JJX07DG188)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TALC (UNII: 7SEV7J4R1U)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69512-001-0115 in 1 BOX
    18.5 g in 1 PATCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/21/2015
    Labeler - Alivio Medical Products, LLC (079670828)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Bangli Medical Products Co.,Ltd421295875manufacture(69512-001)
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