Label: ZENOL COOL- methyl salicylate, l-menthol patch
- NDC Code(s): 72988-0026-1
- Packager: Lydia Co., Ltd.
- 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 July 6, 2023
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
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INGREDIENTS AND APPEARANCE
ZENOL COOL
methyl salicylate, l-menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72988-0026 Route of Administration TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL 140 mg in 6.8 g METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 160 mg in 6.8 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) KAOLIN (UNII: 24H4NWX5CO) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72988-0026-1 6.8 g in 1 POUCH; Type 0: Not a Combination Product 10/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 10/01/2021 Labeler - Lydia Co., Ltd. (695735569) Registrant - Lydia Co., Ltd. (695735569) Establishment Name Address ID/FEI Business Operations Lydia Co., Ltd. 695735569 manufacture(72988-0026) , label(72988-0026)