1ST MEDXPATCH WITH LIDOCAINE 4%-RX by Direct Rx Medx Patch

1ST MEDXPATCH WITH LIDOCAINE 4%-RX by

Drug Labeling and Warnings

1ST MEDXPATCH WITH LIDOCAINE 4%-RX by is a Prescription medication manufactured, distributed, or labeled by Direct Rx. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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.

----------

Medx Patch

CAPSAICIN O.O375%

LIDOCAINE 4%

MENTHOL 5%

METHYL SALICYLATE 20%

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

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.

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.

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.

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.

STORE BELOW 90°F/32°C

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.

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

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 72189-144(NDC: 72137-113)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	20 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.0375 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72189-144-10	10 in 1 PATCH; Type 0: Not a Combination Product	10/14/2020	10/09/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/14/2020	10/09/2023

Labeler - Direct Rx (079254320)

Registrant - Direct Rx (079254320)

Establishment
Name	Address	ID/FEI	Business Operations
Direct Rx		079254320	repack(72189-144)

Revised: 10/2023

Document Id: 07ee2011-53a2-3bdd-e063-6294a90aaf4d

34391-3

Set id: b1a6745f-03fa-1458-e053-2a95a90afeac

Version: 2

Effective Time: 20231017