1st Medx (as Pld) - Patch With Lidocaine 4%-rx (72137-113) - Delist

1st Medx (as Pld) - Patch With Lidocaine 4%-rx (72137-113) - Delist
SPL v11
SPL
SPL Set ID b55585cf-45da-4b78-b68e-f7dddf23bfe7
Route
TOPICAL
Published
Effective Date 2019-07-19
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.0375 g) Lidocaine (4 g) Menthol (5 g) Salicylic Acid (20 g)
Inactive Ingredients
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

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2018-03-15

Description

CAPSAICIN O.O375% LIDOCAINE 4% MENTHOL 5% METHYL SALICYLATE 20%


Medication Information

Description

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.

Section 43685-7

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.
Section 50565-1

KEEP OUT OF REACH OF CHILDREN.

IF SWALLOWED, CALL POISON CONTROL

Section 51945-4

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.
Questions?

888-319-6339

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

Active Ingredients:

CAPSAICIN O.O375%

LIDOCAINE 4%

MENTHOL 5%

METHYL SALICYLATE 20%

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.


Structured Label Content

Uses: (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.

Section 43685-7 (43685-7)

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.
Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN.

IF SWALLOWED, CALL POISON CONTROL

Section 51945-4 (51945-4)

Warnings: (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.
Questions? (QUESTIONS?)

888-319-6339

Directions: (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: (OTHER INFORMATION:)

STORE BELOW 90°F/32°C

Active Ingredients: (ACTIVE INGREDIENTS:)

CAPSAICIN O.O375%

LIDOCAINE 4%

MENTHOL 5%

METHYL SALICYLATE 20%

Inactive Ingredients: (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.


Advanced Ingredient Data


Raw Label Data

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