FDA.reportPublic FDA data

ZYLOTROL PAIN RELIEVING CREAM

Manufacturer
Whitestone Products LLC
Effective date
2024-09-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:20:01

Label at a glance#

ProductZYLOTROL PAIN RELIEVING
Active ingredientLIDOCAINE HYDROCHLORIDE, MENTHOL, UNSPECIFIED FORM
Label structure9 sections

Label contents#

Full prescribing information#

Active ingredients 

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 4.0%

Menthol 1.0%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic, Anesthetic

INDICATIONS & USAGE SECTION

Uses

For temporarily relief of pain

WARNINGS SECTION

Warnings 

For external use only.

Ask a doctor before use ifyou have a heart condition.

Do not use •if you are allergic to any other type of numbing medicine •in large quantities, particularly over raw surfaces or blistered areas •on infections •on deep puncture wounds •if pregnant or breastfeeding.

When using this product •do not use over large skin areas •do not apply heat, bandages or plastic wrap to treated areas •do not use in or near the eyes •wash hands immediately after using.

Stop use and ask a doctor if •allergic reaction occurs •condition worsens or does not improve within 7 days •symptoms clear up and return within a few days •redness, irritation, swelling, pain or other symptoms begin or increase.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

Apply generously up to 3 to 4 times daily. For use on adults and children 12 years and older. Children under 12 - ask a doctor.

INACTIVE INGREDIENT SECTION

Inactive ingredients:

Allantoin, Aloe Barbadensis Leaf Juice*, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arnica Montana Flower Extract, Behenyl Alcohol, Boswellia Serrata Extract, Butyrospermum Parkii (Shea) Butter, Calophyllum Inophyllum (Tamanu) Seed Oil, Caprylic/capric Triglyceride, Ceteareth-20, Cetearyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Ethylhexylglycerin, Hypericum Perforatum (St. John's Wort) Flower/leaf/stem Extract, Glyceryl Stearate, Glycerin, Hydrogenated Polydecene, Isopropyl Palmitate, Peg-100 Stearate, Persea Gratissima (Avocado) Oil, Phenoxyethanol, Polysorbate 60, Propanediol, Sodium Polyacrylate, Stearyl Alcohol, Tetrahydroxypropyl Ethylenediamine, Trideceth-6, Water.

*Certified Organic Ingredient - Mayacert Certifier

OTC - QUESTIONS SECTION

Questions?

(310) 320-0100

PRINCIPAL DISPLAY PANEL-Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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PRINCIPAL DISPLAY PANEL-Jar Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1595624lidocaine HCl 4 % / menthol 1 % Topical CreamPSN3
1595624lidocaine hydrochloride 40 MG/ML / menthol 10 MG/ML Topical CreamSCD3
1595624lidocaine hydrochloride 4 % / menthol 1 % Topical CreamSY3

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
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
81902-230-01ZYLOTROL PAIN RELIEVING102 g in 1 TUBECREAM1023
81902-230-02ZYLOTROL PAIN RELIEVING102 g in 1 JARCREAM1023

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81902-230ZYLOTROL PAIN RELIEVING (LIDOCAINE HCL, MENTHOL) CREAM [WHITESTONE PRODUCTS LLC]3Current NDC, Legacy NDC, 2 package rows20240924_2301fed7-0fa9-450d-8b1b-006f53235be0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81902-230-01GM - Gram81902-230a0ffe8f5-dc3b-4a71-bc6d-378595bd6ff712023-04-07
81902-230-02GM - Gram81902-2303c17f3a7-2555-4d51-b8c2-64538b2f965912024-10-04

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81902-23081902-230-01, 81902-230-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
PROPANEDIOL5965N8W85TIACT
GLYCERINPDC6A3C0OXIACT
STEARYL ALCOHOL2KR89I4H1YIACT
SHEA BUTTERK49155WL9YIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
DOCOSANOL9G1OE216XYIACT
EDETOLQ4R969U9FRIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
ALLANTOIN344S277G0ZIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
AVOCADO OIL6VNO72PFC1IACT
TAMANU OILJT3LVK84A1IACT
POLYSORBATE 60CAL22UVI4MIACT
ALOE VERA LEAFZY81Z83H0XIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
CHAMOMILEFGL3685T2XIACT
ST. JOHN'S WORTUFH8805FKAIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
HYDROGENATED POLYDECENE (550 MW)U333RI6EB7IACT
TRIDECETH-63T5PCR2H0CIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZYLOTROL PAIN RELIEVINGLIDOCAINE HCL, MENTHOLWhitestone Products LLC2301fed7-0fa9-450d-8b1b-006f53235be02024-09-21WarningsExact identifier
ndc (package): 81902-230-02
ndc (package): 81902-230-01
ndc (product): 81902-230
ndc11 (package): 81902023002
ndc11 (package): 81902023001
spl id: 229a56ae-aced-33d9-e063-6394a90a477d
spl set id: 2301fed7-0fa9-450d-8b1b-006f53235be0

Reported adverse events (FAERS/openFDA)#

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