FDA.reportPublic FDA data

Zylotrol

Manufacturer
Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM
Effective date
2023-10-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:56:48

Label at a glance#

ProductZylotrol
Active ingredientLIDOCAINE HYDROCHLORIDE, MENTHOL, UNSPECIFIED FORM
Label structure15 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Lidocaine HCl 4%

Menthol 1%

OTC - PURPOSE SECTION

Purpose

Topical Analgesic

INDICATIONS & USAGE SECTION

Uses

For the temporary relief of pain.

WARNINGS SECTION

Warnings

For external use only not intended for ingestion.

OTC - DO NOT USE SECTION

Do not use

  • in large quantities, particularly over raw surfaces, or blistered areas.

OTC - WHEN USING SECTION

When using this product

  • Avoid contact with the eyes.

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if

  • condition worsens, or if symtoms persist for more than 7 days or clear up and occur again within a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times a daily.
  • Children under 2 years of age: consult a doctor.

OTHER SAFETY INFORMATION

Other information

  • Store at 20-25 oC (68-77 oF) and protect from moisture.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Carbomer, Ethylhexylglycerin, Isopropyl Alcohol, Phenoxyethanol, Triethanolamine.

OTC - QUESTIONS SECTION

Questions?

(310) 320-0100

SPL UNCLASSIFIED SECTION

Relabeled by:
Enovachem PHARMACEUTICALS
Torrance, CA 90501

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1373137lidocaine HCl 4 % / menthol 1 % Topical GelPSN3
1373137lidocaine hydrochloride 0.04 MG/MG / menthol 0.01 MG/MG Topical GelSCD3
1373137lidocaine hydrochloride 4 % / menthol 1 % Topical GelSY3

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-145-04Zylotrol1 in 1 BOXGEL13
76420-145-04Zylotrol118.3 g in 1 TUBEGEL118.33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-145ZYLOTROL (LIDOCAINE HCL 4%, MENTHOL 1%) GEL [ASCLEMED USA, INC.]3Current NDC, Legacy NDC, 2 package rows20231016_e13984ea-73a9-2894-e053-2995a90a8ed6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-145-04ML - Milliliter76420-145304a6a5c-65f1-4b11-9127-1dd4eaa6a34d12022-08-04
81902-201-04GM - Gram81902-20162dab991-3aed-49ac-ae23-e0c9e8341ad922023-06-06

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76420-14576420-145-04
81902-201

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ISOPROPYL ALCOHOLND2M416302IACT
PHENOXYETHANOLHIE492ZZ3TIACT
TROLAMINE9O3K93S3TKIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB

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
ZylotrolLIDOCAINE HCL 4%, MENTHOL 1%Asclemed USA, Inc.e13984ea-73a9-2894-e053-2995a90a8ed62023-10-16WarningsExact identifier
ndc (package): 76420-145-04
ndc (product): 76420-145
ndc11 (package): 76420014504
spl id: 07cebfba-4f3b-882f-e063-6294a90ac460
spl set id: e13984ea-73a9-2894-e053-2995a90a8ed6
ZylotrolLIDOCAINE HCL 4%, MENTHOL 1%Whitestone Products LLC0e32e9c0-ff5b-4e88-89b1-f5903cd982092023-10-16WarningsExact identifier
ndc (product): 81902-201

Reported adverse events (FAERS/openFDA)#

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