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

  • NDC Code(s): 72137-555-01, 72137-555-15
  • Packager: 1ST MEDX LLC
  • 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 July 19, 2019

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENTS:

    CAPSAICIN O.O25%

    LIDOCAINE 4%

    MENTHOL 5%

    METHYL SALICYLATE 20%

  • PURPOSE

    TOPICAL ANALGESIC

  • 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

    medx_ndc_72137-555-15_front

    medx_rear_ndc 72137-555-15_back

    Patch Insert_72137-113-15

  • INGREDIENTS AND APPEARANCE
    1ST MEDXPATCH  WITH LIDOCAINE 4%
    lidocaine, capsaicin, menthol, methyl salicylate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72137-555
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.025 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:72137-555-1510 in 1 POUCH03/18/2018
    1NDC:72137-555-011 in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/15/2018
    Labeler - 1ST MEDX LLC (081071002)