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NDC 72137-0113-15 1ST MEDXPATCH .0375; 4; 5; 20 g/1; g/1; g/1; g/1 Details

1ST MEDXPATCH .0375; 4; 5; 20 g/1; g/1; g/1; g/1

1ST MEDXPATCH is a TOPICAL PATCH in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by 1ST MEDX LLC. The primary component is CAPSAICIN; LIDOCAINE; MENTHOL; METHYL SALICYLATE.

Product Information

NDC	72137-0113
Product ID	72137-113_d66c05c3-ee12-5f34-e053-2a95a90a79c1
Associated GPIs	90859904505945
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	1ST MEDXPATCH
Proprietary Name Suffix	WITH LIDOCAINE 4%-RX
Non-Proprietary Name	LIDOCAINE, CAPSAICIN, MENTHOL, METHYL SALICYLATE
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	PATCH
Route	TOPICAL
Active Ingredient Strength	.0375; 4; 5; 20
Active Ingredient Units	g/1; g/1; g/1; g/1
Substance Name	CAPSAICIN; LIDOCAINE; MENTHOL; METHYL SALICYLATE
Labeler Name	1ST MEDX LLC
Pharmaceutical Class	Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2023-12-31

Package

Package Images

NDC 72137-0113-15 (72137011315)

Pricing Information	N/A
NDC Package Code	72137-113-15
Billing NDC	72137011315
Package	10 PATCH in 1 POUCH (72137-113-15) / 1 PATCH in 1 PATCH (72137-113-01)
Marketing Start Date	2018-03-18
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b55585cf-45da-4b78-b68e-f7dddf23bfe7 Details

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.

SPL UNCLASSIFIED SECTION

KEEP OUT OF REACH OF CHILDREN.

IF SWALLOWED, CALL POISON CONTROL

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:72137-113-15	10 in 1 POUCH	03/18/2018
1	NDC:72137-113-01	1 in 1 PATCH; Type 0: Not a Combination Product

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

Labeler - 1ST MEDX LLC (081071002)

Revised: 1/2022

Document Id: d66c05c3-ee12-5f34-e053-2a95a90a79c1

Set id: b55585cf-45da-4b78-b68e-f7dddf23bfe7

Version: 7

Effective Time: 20220125

Search by Drug Name or NDC

NDC 72137-0113-15 1ST MEDXPATCH .0375; 4; 5; 20 g/1; g/1; g/1; g/1 Details

1ST MEDXPATCH .0375; 4; 5; 20 g/1; g/1; g/1; g/1

Product Information

Package

Package Images

NDC 72137-0113-15 (72137011315)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL b55585cf-45da-4b78-b68e-f7dddf23bfe7 Details

ACTIVE INGREDIENTS:

USES:

WARNINGS:

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

DIRECTIONS:

OTHER INFORMATION:

INACTIVE INGREDIENTS:

QUESTIONS?

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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