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

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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1ST MEDX-PATCH WITH LIDOCAINE 4%-RX

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.

KEEP OUT OF REACH OF CHILDREN.

IF SWALLOWED, CALL POISON CONTROL

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

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

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

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Patch Insert_72137-113-15

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 
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE20 
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)

Revised: 7/2019
Document Id: 63ea416d-3d6e-4e91-8a9e-08006178cf3a
Set id: b55585cf-45da-4b78-b68e-f7dddf23bfe7
Version: 5
Effective Time: 20190719
 
1ST MEDX LLC