Prescription Drug Information: 1ST MEDXPATCH WITH LIDOCAINE 4%-RX

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

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.

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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE (LIDOCAINE) LIDOCAINE 4
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 20
CAPSAICIN (CAPSAICIN) CAPSAICIN 0.0375
MENTHOL (MENTHOL) MENTHOL 5
Inactive Ingredients
Ingredient Name Strength
POLYACRYLIC ACID (450000 MW)
ISOPROPYL MYRISTATE
SORBITOL
PROPYLPARABEN
TITANIUM DIOXIDE
POLYSORBATE 80
PROPYLENE GLYCOL
GLYCERIN
SODIUM POLYACRYLATE (2500000 MW)
DIHYDROXYALUMINUM AMINOACETATE
TARTARIC ACID
EDETATE DISODIUM
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72189-144-10 10 PATCH in 1 PATCH None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/14/2020
Labeler — Direct Rx (079254320)
Registrant — Direct Rx (079254320)
Establishment
Name Address ID/FEI Operations
Direct Rx 079254320 repack (72189-144)

Revised: 10/2020 Direct Rx

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