NDC | 72137-113-01, 72137-113-15 |
Set ID | b55585cf-45da-4b78-b68e-f7dddf23bfe7 |
Category | HUMAN PRESCRIPTION DRUG LABEL |
Packager | 1ST MEDX LLC |
Generic Name | |
Product Class | Amide Local Anesthetic, Antiarrhythmic |
Product Number | |
Application Number |
- ACTIVE INGREDIENTS:
- 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.
Close - 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
- WARNINGS AND PRECAUTIONS
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.
Close - OTHER INFORMATION:
- 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.
Close - QUESTIONS?
- INGREDIENTS AND APPEARANCE
1ST MEDXPATCH WITH LIDOCAINE 4%-RX
lidocaine, capsaicin, menthol, methyl salicylate patchProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72137-113 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.0375 LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5 METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 20 Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 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) Establishment Name Address ID/FEI Business Operations Henan Kangdi Medical Devices Co. Ltd. 421288241 manufacture(72137-113)