NDC 76420-145

Zylotrol

Lidocaine Hcl 4%, Menthol 1%

Zylotrol is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Asclemed Usa, Inc.. The primary component is Lidocaine Hydrochloride; Menthol, Unspecified Form.

Product ID76420-145_e1397fb0-855f-7a40-e053-2995a90a35bb
NDC76420-145
Product TypeHuman Otc Drug
Proprietary NameZylotrol
Generic NameLidocaine Hcl 4%, Menthol 1%
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2022-06-12
Marketing CategoryOTC MONOGRAPH NOT FINAL /
Application Numberpart348
Labeler NameAsclemed USA, Inc.
Substance NameLIDOCAINE HYDROCHLORIDE; MENTHOL, UNSPECIFIED FORM
Active Ingredient Strength4 g/100g; g/100g
Pharm ClassesAmide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 76420-145-04

1 TUBE in 1 BOX (76420-145-04) > 118.3 g in 1 TUBE
Marketing Start Date2022-06-12
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Zylotrol" or generic name "Lidocaine Hcl 4%, Menthol 1%"

NDCBrand NameGeneric Name
76420-145ZylotrolLidocaine HCl 4%, Menthol 1%
76420-504ZylotrolLidocaine 4%, Menthol 4%
81902-130ZylotrolLidocaine 4%, Menthol 4%
81902-201ZylotrolLidocaine HCl 4%, Menthol 1%

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