Label: MEDI-PATCH WITH LIDOCAINE RX- capsaicin, lidocaine, menthol, and methyl salicylate patch

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated September 12, 2013

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  • ACTIVE INGREDIENT

    CAPSAICIN 0.035%

    LIDOCAINE 0.5%

    MENTHOL 5%

    METHYL SALICYLATE 20%

  • PURPOSE

    PURPOSE

    TOPICAL ANALGESIC

    TOPICAL ANESTHETIC

  • INDICATIONS & USAGE

    USES: FOR THE TEMPORARY RELIEF OF MINOR ACHES AND PAINS OF MUSCLES AND JOINTS ASSOCIATED WITH ARTHRITIS, SIMPLE BACKACHE, STRAINS, SPRAINS, MUSCLE SORENESS AND STIFFNESS.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS:

    USE AS DIRECTED. PRIOR TO USE, CLEAN AND DRY AFFECTED AREA. REMOVE PROTECTIVE FILM AND APPLY DIRECTLY TO AFFECTED AREA. DO NOT USE MORE THAN 3 TIMES A DAY. THOROUGHLY WASH HANDS AFTER APPLICATION. RESEAL POUCH AFTER OPENING.

  • INACTIVE INGREDIENT

    Inactive Ingredients: ACRLIC ACID, ALUMINUM HYDROXIDE, CARMELLOSE SODIEM, 2-ETHYLHEXYL ACRYLATE, GLYCERIN, ISOPROPYL MYRISTATE, METHYL ACRYLATE, NONOXYNOL-30, POLYACRYLATE, POLYACRYLIC ACID, POLYSORBATE 80, SORBITAN SESQUIOLEATE, STARCH, TALC, TARTARIC ACID, TITANIUM DIOXIDE, WATER.

  • OTHER SAFETY INFORMATION

    OTHER INFORMATION: STORE BELOW 90°F/32°C

  • QUESTIONS

    QUESTIONS? 888 907-2833

  • ASK DOCTOR

    IF CONDITION WORSENS, OR IF SYMPTOMS PERSIST FOR MORE THAN 7 DAYS OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS, DISCONTINUE USE OF THIS PRODUCT AND CONSULT A DOCTOR.

  • PREGNANCY

    IF PREGNANT OR NURSING ASK A HEALTH PROFESSIONAL BEFORE USE.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • WARNINGS

    Warnings: For external use only. Use only as directed. Avoid contact with eyes and mucous membranes. Do not use with heating devices or pads. Do not cover or bandage tightly. If swallowed, call poison control. If contact does occur with eyes rinse with cold water and call a doctor.

  • DO NOT USE

    DO NOT USE:

    • ON WOUNDS OR DAMAGED SKIN.
    • CHILDREN UNDER 12 YEARS OLD, CONSULT A DOCTOR.
    • IF YOU ARE ALLERGIC TO ANY INGREDIENTS IN THIS PRODUCT.
  • PRINCIPAL DISPLAY PANEL

    Medi-Patch-Rx_153-21_LBL

  • INGREDIENTS AND APPEARANCE
    MEDI-PATCH WITH LIDOCAINE  RX
    capsaicin, lidocaine, menthol, and methyl salicylate patch
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:76074-153
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.5 g
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.0175 g
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.25 g
    Inactive Ingredients
    Ingredient NameStrength
    ACRYLIC ACID (UNII: J94PBK7X8S)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ETHYLHEXYL ACETATE (UNII: 2C7K8OA8SB)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYL ACRYLATE (UNII: WC487PR91H)  
    NONOXYNOL-30 (UNII: JJX07DG188)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    POLYACRYLIC ACID (800000 MW) (UNII: D0I6NSZ87U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76074-153-411 in 1 POUCH
    1NDC:76074-153-211 in 1 PATCH
    2NDC:76074-153-515 in 1 BOX
    2NDC:76074-153-211 in 1 PATCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/18/2012
    Labeler - Two Hip Consulting, LLC (965352896)
    Registrant - Two Hip Consulting, LLC (965352896)
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