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NDC 76420-0504-15 Zylotrol 4; 4 g/100g; g/100g Details
Zylotrol 4; 4 g/100g; g/100g
Zylotrol is a TOPICAL PATCH in the HUMAN OTC DRUG category. It is labeled and distributed by Asclemed USA, Inc.. The primary component is LIDOCAINE; MENTHOL, UNSPECIFIED FORM.
Product Information
NDC | 76420-0504 |
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Product ID | 76420-504_ead97aa4-5942-b457-e053-2a95a90a46f1 |
Associated GPIs | |
GCN Sequence Number | 071052 |
GCN Sequence Number Description | lidocaine/menthol ADH. PATCH 4 %-4 % TOPICAL |
HIC3 | Q5H |
HIC3 Description | TOPICAL LOCAL ANESTHETICS |
GCN | 34737 |
HICL Sequence Number | 007837 |
HICL Sequence Number Description | LIDOCAINE/MENTHOL |
Brand/Generic | Generic |
Proprietary Name | Zylotrol |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Lidocaine 4%, Menthol 4% |
Product Type | HUMAN OTC DRUG |
Dosage Form | PATCH |
Route | TOPICAL |
Active Ingredient Strength | 4; 4 |
Active Ingredient Units | g/100g; g/100g |
Substance Name | LIDOCAINE; MENTHOL, UNSPECIFIED FORM |
Labeler Name | Asclemed USA, Inc. |
Pharmaceutical Class | Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH NOT FINAL |
Application Number | part348 |
Listing Certified Through | 2023-12-31 |
Package
Package Images

NDC 76420-0504-15 (76420050415)
NDC Package Code | 76420-504-15 |
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Billing NDC | 76420050415 |
Package | 15 PATCH in 1 BOX (76420-504-15) / 4 g in 1 PATCH |
Marketing Start Date | 2022-10-12 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL ead97a8e-da50-b6aa-e053-2a95a90a0a8b Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Directions: Adults 18 years and older - apply patch to affected area 1 to 2 times daily or as directed by your physician. Clean and dry affected area. Open pouch, remove one patch and remove protective film. Apply to affected area and leave in place for 8 to 12 hours. Only use one patch at a time. Do not use more than 2 patches per day. Reseal pouch containing unused patches after each use. Not indicated for children under 18 years of age.
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
ZYLOTROL
lidocaine 4%, menthol 4% patch |
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Labeler - Asclemed USA, Inc. (059888437) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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ASCLEMED USA INC. DBA ENOVACHEM | 059888437 | relabel(76420-504) |
Revised: 10/2022
Document Id: ead97aa4-5942-b457-e053-2a95a90a46f1
Set id: ead97a8e-da50-b6aa-e053-2a95a90a0a8b
Version: 1
Effective Time: 20221012