FDA.reportPublic FDA data

ZYLOTROL MAXIMUM PAIN PATCH

Manufacturer
Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM
Effective date
2023-10-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:57:05

Label at a glance#

ProductZYLOTROL MAXIMUM PAIN
Active ingredientMENTHOL, LIDOCAINE
Label structure14 sections

Indications and uses

For the temporary relief of pain.

Dosage and administration

Adult and children 12 years of age and over: Clean and dry affected area Remove film from patch and apply to the skin (see illustration) Apply 1 patch at a time to affected area, not more than 3 to 4 times daily Remove patch from the skin after at most 8-hour application Children under 12 years of age: Consult a doctor

Storage and handling

Store at 68-77℉ (20-25℃) Store in a cool dry place away from direct sunlight

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4% w/w

Menthol 1% w/w

Purposes

OTC - PURPOSE SECTION

Topical analgesic

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain.

Warnings

WARNINGS SECTION

For external use only

Do not use:

OTC - DO NOT USE SECTION

  • More than 1 patch at a time
  • On wounds or damaged skin
  • For more than one week without consulting a doctor
  • If you are allergic to any ingredients of this product

When using this product:

OTC - WHEN USING SECTION

  • Use only as directed
  • Avoid contact with the eyes, mucous membranes or rashes
  • Do not bandage tightly

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • Condition worsen
  • Symptoms persist for more than 7 days
  • Symptoms clear up and occur again within a few days

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

Adult and children 12 years of age and over:

  • Clean and dry affected area
  • Remove film from patch and apply to the skin (see illustration)
  • Apply 1 patch at a time to affected area, not more than 3 to 4 times daily
  • Remove patch from the skin after at most 8-hour application

Children under 12 years of age: Consult a doctor

Other information

STORAGE AND HANDLING SECTION

  • Store at 68-77℉ (20-25℃)
  • Store in a cool dry place away from direct sunlight

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Polyacrylic Acid, Propylene Glycol, Sodium Polyacrylate, Polysorbate 80, Mineral oil, Polyvinylpyrrolidone K90, Hydroxyacetophenone, L(+)-Tartaric Acid, Dihydroxyaluminium Aminoacetate, Edetate Disodium, Kaolin, Titanium Dioxide

Questions?

OTC - QUESTIONS SECTION

(310) 320-0100

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1249758lidocaine 4 % / menthol 1 % Medicated PatchPSN2
1249758lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCD2
1249758lidocaine 4 % / menthol 1 % Medicated PatchSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-581-15ZYLOTROL MAXIMUM PAIN15 in 1 BOXPATCH152
76420-581-15ZYLOTROL MAXIMUM PAIN3 g in 1 PATCHPATCH32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-581ZYLOTROL MAXIMUM PAIN (LIDOCAINE 4%, MENTHOL 1%) PATCH [ASCLEMED USA, INC.]2Current NDC, 2 package rows20231021_0bdfe510-c2ff-4f23-9e9b-6ec6cb5c91dd.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-581-15EA - Each76420-58175cec7b3-0113-4815-b531-04d1884c56bf12023-07-06
81902-104-15EA - Each81902-104c498d81e-2515-4da8-9ee2-b17d3ba709c512023-04-07

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76420-58176420-581-15
81902-104

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
KAOLIN24H4NWX5COIACT
TARTARIC ACIDW4888I119HIACT
WATER059QF0KO0RIACT
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS1K713C615KIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POLYACRYLIC ACID (250000 MW)9G2MAD7J6WIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
MINERAL OILT5L8T28FGPIACT
POLYSORBATE 806OZP39ZG8HIACT
GLYCERINPDC6A3C0OXIACT
EDETATE DISODIUM7FLD91C86KIACT
POVIDONE K90RDH86HJV5ZIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
MENTHOLL7T10EIP3AACTIB
LIDOCAINE98PI200987ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZYLOTROL MAXIMUM PAINLIDOCAINE 4%, MENTHOL 1%Whitestone Products LLCa80efad7-1d8b-4d8b-8c97-373174ce89ca2026-08-21WarningsExact identifier
ndc (product): 81902-104
ZYLOTROL MAXIMUM PAINLIDOCAINE 4%, MENTHOL 1%Asclemed USA, Inc.0bdfe510-c2ff-4f23-9e9b-6ec6cb5c91dd2023-10-20WarningsExact identifier
ndc (package): 76420-581-15
ndc (product): 76420-581
ndc11 (package): 76420058115
spl id: 0831d32f-b4cd-6e8b-e063-6294a90a38b8
spl set id: 0bdfe510-c2ff-4f23-9e9b-6ec6cb5c91dd

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.