FDA.reportPublic FDA data

MAXOCAINE PAIN RELIEVING ROLL-ON

Manufacturer
Prime Commerce, LLC
Effective date
2023-11-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:00:14

Label at a glance#

ProductMAXOCAINE PAIN RELIEVING ROLL-ON
Active ingredientLIDOCAINE HYDROCHLORIDE, MENTHOL
Label structure7 sections

Dosage and administration

 Apply to affected area not more than three to four times daily.  consult a physician. Adults and children two-years of age or older: Chinldren under two-years of age: 

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lydocaine HCL 4%

Menthol 1%

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

Use:

INDICATIONS & USAGE SECTION

For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritations.

Warnings:

WARNINGS SECTION

  • For external use only
  • Avoid contact with eyes.
  • If symptoms persist for more than seven days, discontinue use and consult physician.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, consult physician.

Do not apply

OTC - DO NOT USE SECTION

  • to wounds or damaged skin.
  • Do not bandage tightly.

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

contact physician prior to use.

Directions:

DOSAGE & ADMINISTRATION SECTION

 Apply to affected area not more than three to four times daily.  consult a physician. Adults and children two-years of age or older: Chinldren under two-years of age: 

Additional Information:

SPL UNCLASSIFIED SECTION

Store at room temperature.

Inactive Information:

INACTIVE INGREDIENT SECTION

Acrylates C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Extract, Boswellia Serrata Extract, Cetyl Alcohol, Ethylhexylglycerin, Ilex Paraguayensis (Yerba Mate') Extract, Isopropyl Alcohol, Isopropyl Myristate, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate-20, Sodium Lauryl Sulfate, Stearic Acid, Triethanolamine

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2002008lidocaine HCl 4 % / menthol 1 % Topical SolutionPSN3
2002008lidocaine hydrochloride 40 MG/ML / menthol 10 MG/ML Topical SolutionSCD3
2002008lidocaine HCl 4 % / menthol 1 % Topical SolutionSY3

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
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72188-170-03MAXOCAINE PAIN RELIEVING ROLL-ON88 mL in 1 BOTTLE, WITH APPLICATORLIQUID883

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72188-170MAXOCAINE PAIN RELIEVING ROLL-ON (LIDOCAINE HYDROCHLORIDE, MENTHOL) LIQUID [PRIME COMMERCE, LLC]3Current NDC, Legacy NDC, 1 package rows20231112_c263d5f2-89b9-4dfd-91c8-f894e5f956c9.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72188-17072188-170-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ARNICA MONTANAO80TY208ZWIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
CETYL ALCOHOL936JST6JCNIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
ISOPROPYL ALCOHOLND2M416302IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
SODIUM LAURYL SULFATE368GB5141JIACT
STEARIC ACID4ELV7Z65APIACT
TROLAMINE9O3K93S3TKIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
MENTHOLL7T10EIP3AACTIB

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
MAXOCAINE PAIN RELIEVING ROLL-ONLIDOCAINE HYDROCHLORIDE, MENTHOLPrime Commerce, LLCc263d5f2-89b9-4dfd-91c8-f894e5f956c92023-11-11WarningsExact identifier
ndc (package): 72188-170-03
ndc (product): 72188-170
ndc11 (package): 72188017003
spl id: 09dc681e-2348-4213-e063-6394a90a41e1
spl set id: c263d5f2-89b9-4dfd-91c8-f894e5f956c9

Reported adverse events (FAERS/openFDA)#

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