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

  • NDC Code(s): 72137-113-01, 72137-113-15
  • Packager: 1ST MEDX LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 25, 2022

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  • ACTIVE INGREDIENTS:

    CAPSAICIN O.O375%

    LIDOCAINE 4%

    MENTHOL 5%

    METHYL SALICYLATE 20%

  • 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.

  • 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.
  • DIRECTIONS:

    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 INFORMATION:

    STORE BELOW 90°F/32°C

  • INACTIVE INGREDIENTS:

    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.

  • QUESTIONS?

    888-319-6339

  • PRINCIPAL DISPLAY PANEL

    1st Medx_Patch_LBL_Front_10 count

    1st Medx_Patch_LBL_Back_10 count

    Patch Insert_72137-113-15

  • INGREDIENTS AND APPEARANCE
    1ST MEDXPATCH  WITH LIDOCAINE 4%-RX
    lidocaine, capsaicin, menthol, methyl salicylate patch
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72137-113
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.0375 g
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE20 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYACRYLIC ACID (450000 MW) (UNII: KD3S7H73D3)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    TARTARIC ACID (UNII: W4888I119H)  
    SORBITOL (UNII: 506T60A25R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72137-113-1510 in 1 POUCH03/18/2018
    1NDC:72137-113-011 in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/15/2018
    Labeler - 1ST MEDX LLC (081071002)
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