Label: MENTHOL 6.5%- menthol, unspecified form patch
- NDC Code(s): 71391-124-18, 71391-124-36
- Packager: Unexo Life Sciences, Private Limited
- 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 January 18, 2022
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- SPL UNCLASSIFIED SECTION
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- PRINCIPAL DISPLAY PANEL - 1 Patch Pouch
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INGREDIENTS AND APPEARANCE
MENTHOL 6.5%
menthol, unspecified form patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71391-124 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength menthol, unspecified form (UNII: L7T10EIP3A) (menthol, unspecified form - UNII:L7T10EIP3A) menthol, unspecified form 910 mg Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) DMDM hydantoin (UNII: BYR0546TOW) DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6) WHITE WAX (UNII: 7G1J5DA97F) Edetate Sodium (UNII: MP1J8420LU) Glycerin (UNII: PDC6A3C0OX) Polysorbate 20 (UNII: 7T1F30V5YH) Polyvinyl Alcohol, Unspecified (UNII: 532B59J990) POVIDONE K60 (UNII: SZR7Z3Q2YH) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) Tartaric acid (UNII: W4888I119H) Titanium dioxide (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71391-124-18 18 in 1 BOX 04/01/2020 1 1 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:71391-124-36 36 in 1 BOX 04/01/2020 2 1 in 1 POUCH; 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 04/01/2020 Labeler - Unexo Life Sciences, Private Limited (872260479) Establishment Name Address ID/FEI Business Operations Unexo Life Sciences, Private Limited 872260479 MANUFACTURE(71391-124)