Label: LIDOZEN- lidocaine hydrochloride, menthol patch
- NDC Code(s): 71574-800-05
- Packager: Village Pharma LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 29, 2023
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- DRUG FACTS:
- ACTIVE INGREDIENTS:
- USES:
- WARNINGS:
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DIRECTIONS (Adults and Children Over 12 Years):
Clean and dry affected area.
Remove patch from backing and apply to affected area.
Use only one patch at a time, and maximum of four patches / day.
Leave patch on affected area for up to 8 hours.
Do not use patches for longer than five consective days.
Children under 12 should consult physician prior to use.
- INACTIVE INGREDIENTS:
- SPL UNCLASSIFIED SECTION
- Package Labeling:
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INGREDIENTS AND APPEARANCE
LIDOZEN
lidocaine hydrochloride, menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71574-800 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 40 mg in 1 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 mg in 1 g Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6) ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) KAOLIN (UNII: 24H4NWX5CO) POLYSORBATE 80 (UNII: 6OZP39ZG8H) TARTARIC ACID (UNII: W4888I119H) EDETATE SODIUM (UNII: MP1J8420LU) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) PHENOXYETHANOL (UNII: HIE492ZZ3T) UREA (UNII: 8W8T17847W) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71574-800-05 5 in 1 POUCH 05/01/2019 1 1 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 05/01/2019 Labeler - Village Pharma LLC (080749749)