NDC | 72137-555-01, 72137-555-15 |
Set ID | 852b3ee7-2644-4faf-8528-b1db9f3d551b |
Category | HUMAN OTC DRUG LABEL |
Packager | 1ST MEDX LLC |
Generic Name | |
Product Class | Amide Local Anesthetic, Antiarrhythmic |
Product Number | |
Application Number | PART348 |
- ACTIVE INGREDIENTS:
- PURPOSE
- USES:
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN
- WARNINGS AND PRECAUTIONS
- DIRECTIONS:
- OTHER INFORMATION:
- INACTIVE INGREDIENTS:
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
1ST MEDXPATCH WITH LIDOCAINE 4%
lidocaine, capsaicin, menthol, methyl salicylate patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72137-555 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.025 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 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:72137-555-15 10 in 1 POUCH 03/18/2018 1 NDC:72137-555-01 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 OTC monograph not final part348 03/15/2018 Labeler - 1ST MEDX LLC (081071002)