Label: MEDI-SULTING TOPICAL PAIN RELIEF- methyl salicylate menthol capsaicin lidocaine 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 February 6, 2019

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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.

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions: Use only as directed. Prior to first use, test skin sensitivity by applying a small amount. Apply and massage directly to affected area. Do not use more than 4 times a day. Thoroughly wash hands after application.

  • 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.

  • PRINCIPAL DISPLAY PANEL

    Medi-Patch_123-21_LBL

  • INGREDIENTS AND APPEARANCE
    MEDI-SULTING TOPICAL PAIN RELIEF 
    methyl salicylate menthol capsaicin lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76074-123
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE20 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 g
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN.035 g  in 100 g
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.5 g  in 100 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:76074-123-2110 g in 1 PATCH; Type 0: Not a Combination Product03/12/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/18/2012
    Labeler - Two Hip Consulting, LLC (965352896)
    Registrant - Two Hip Consulting, LLC (965352896)
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