1ST MEDXPATCH WITH LIDOCAINE 4%-RX

1ST MEDXPATCH WITH LIDOCAINE 4%-RX- capsaicin, lidocaine, menthol and 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.

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.

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.

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

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

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

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPSAICIN (CAPSAICIN) CAPSAICIN 0.0375 g LIDOCAINE (LIDOCAINE) LIDOCAINE 4 g MENTHOL (MENTHOL) MENTHOL 5 g METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 20 g

Inactive Ingredients Ingredient Name Strength GLYCERIN POLYACRYLIC ACID (450000 MW) PROPYLENE GLYCOL SODIUM POLYACRYLATE (2500000 MW) DIHYDROXYALUMINUM AMINOACETATE ISOPROPYL MYRISTATE TARTARIC ACID SORBITOL EDETATE DISODIUM PROPYLPARABEN POLYSORBATE 80 TITANIUM DIOXIDE WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:72137-113-15 10 PATCH in 1 POUCH contains a PATCH (72137-113-01) 1 NDC:72137-113-01 1 PATCH in 1 PATCH This package is contained within the POUCH (72137-113-15)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/15/2018

Labeler — 1ST MEDX LLC (081071002)

Revised: 01/2022 1ST MEDX LLC