Label: 1ST MEDXPATCH WITH LIDOCAINE 4%-RX- lidocaine, capsaicin, menthol, methyl salicylate patch

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

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Drug Label Information

Updated October 14, 2020

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  • ACTIVE INGREDIENT

    CAPSAICIN O.O375%

    LIDOCAINE 4%

    MENTHOL 5%

    METHYL SALICYLATE 20%

  • PURPOSE

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

  • WARNINGS

    FOR EXTERNAL USE ONLY.

    USE ONLY AS DIRECTED.
    AVOID CONTACT WITH EYES AND MUCOUS MEMBRANES.
    DO NOT USE ON WOUNDS, CUTS, DAMAGED OR INFECTED SKIN AS WELL AS IN THE EYES, MOUTH, GENITALS, OR ANY OTHER MUCOUS MEMBRANES.
    DO NOT COVER WITH BANDAGES.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

    IF SWALLOWED, CALL POISON CONTROL

  • WARNINGS AND PRECAUTIONS

    IF CONTACT DOES OCCUE WITH EYES, RINSE WITH COLD WATER AND CALL A DOCTOR.

    CHILDREN UNDER 12 YEARS OLD, CONSULT A DOCTOR BEFORE USE.

    IF YOU ARE ALLERGIC TO ANY INGREDIENTS IN THIS PRODUCT CONSULT A DOCTOR BEFORE USE.
    CONSULT YOUR PHYSICIAN: IF PREGNANT OR IF PAIN PERSISTS OR WORSENS.

  • WHEN USING

    FOR ADULTS AND CHILDREN 12 YEARS AND OVER. APPLY PATCH TO AFFECTED AREA 1 TO 2 TIMES DAILY OR AS DIRECTED BY PHYSICIAN. CLEAN AND DRY THE AFFECTED AREA. WASH HANDS WITH SOAP AND WATER AFTER APPLYING PATCH. RESEAL POUCH CONTAINING UNUSED PATCHES AFTER USE.

  • OTHER SAFETY INFORMATION

    STORE BELOW 90°F/32°C

  • INACTIVE INGREDIENT

    GLYCERIN 25%, POLYACRYLIC ACID 5%, PROPYLENE GLYCOL 2%, METHYL SALICYLATE, GLYCERIN, SODIUM POLYACRYLATE, DIHYDROXYALUMINUM AMINOACETATE, ISOPROPYL MYRISTATE, TARTARIC ACID, PROPYLENE GLYCOL, SORBITOL, EDTA2-NA, PROPYL P-HYDROXYBENZOATE, TWEEN 80, TITANIUM DIOXIDE, EXTRA MEDICAL PURIFIED WATER.

  • PRINCIPAL DISPLAY PANEL

    14410

  • INGREDIENTS AND APPEARANCE
    1ST MEDXPATCH WITH LIDOCAINE 4%-RX 
    lidocaine, capsaicin, menthol, methyl salicylate patch
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72189-144(NDC:72137-113)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE20 
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.0375 
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 
    Inactive Ingredients
    Ingredient NameStrength
    POLYACRYLIC ACID (450000 MW) (UNII: KD3S7H73D3)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    SORBITOL (UNII: 506T60A25R)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    TARTARIC ACID (UNII: W4888I119H)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72189-144-1010 in 1 PATCH; Type 0: Not a Combination Product10/14/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/14/2020
    Labeler - Direct Rx (079254320)
    Registrant - Direct Rx (079254320)
    Establishment
    NameAddressID/FEIBusiness Operations
    Direct Rx079254320repack(72189-144)
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