Label: 1ST MEDXPATCH WITH LIDOCAINE 4%- lidocaine, capsaicin, menthol, methyl salicylate patch
- NDC Code(s): 72137-555-01, 72137-555-15
- Packager: 1ST MEDX LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated September 28, 2023
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- ACTIVE INGREDIENTS:
- PURPOSE
- USES:
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN
- WARNINGS AND PRECAUTIONS
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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)