FDA.reportPublic FDA data

MAXOCAINE Lidocaine Hemp Oil Topical Analgesic

Manufacturer
Prime Commerce, LLC
Effective date
2023-11-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:00:01

Label at a glance#

ProductMAXOCAINE Lidocaine Hemp Oil Topical Analgesic
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure7 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine hydrochloride 4%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses:

INDICATIONS & USAGE SECTION

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

Warnings:

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

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

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

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.

If pregnant or breast-feeding.

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions:

DOSAGE & ADMINISTRATION SECTION

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

Other Information:

SPL UNCLASSIFIED SECTION

Store at 20-25°C (68-77°F) and protect from moisture.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cannabis Sativa (Hemp) Seed Oil, Carbomer, Dimethicone, Ethylhexylglycerin, Eucalyptus Globulus Oil, Ilex Paraguariensis (Yerba Mate) Extract, Isopropyl Myristate, Mentha Viridis (Spearmint) Oil, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate-20, Triethanolamine.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

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
72188-188-00MAXOCAINE Lidocaine Hemp Oil Topical Analgesic30 mL in 1 BOTTLE, DROPPERSOLUTION302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72188-188MAXOCAINE LIDOCAINE HEMP OIL TOPICAL ANALGESIC (LIDOCAINE HYDROCHLORIDE) SOLUTION [PRIME COMMERCE, LLC]2Current NDC, Legacy NDC, 1 package rows20231112_28ed2149-38d2-4062-8442-990a98a69cfc.zip

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
72188-18872188-188-00

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
WATER059QF0KO0RIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
DIMETHICONE92RU3N3Y1OIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
EUCALYPTUS OIL2R04ONI662IACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
SPEARMINTJ7I2T6IV1NIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
TROLAMINE9O3K93S3TKIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR

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 Lidocaine Hemp Oil Topical AnalgesicLIDOCAINE HYDROCHLORIDEPrime Commerce, LLC28ed2149-38d2-4062-8442-990a98a69cfc2023-11-11WarningsExact identifier
ndc (package): 72188-188-00
ndc (product): 72188-188
ndc11 (package): 72188018800
spl id: 09dc64a4-8591-ddca-e063-6294a90ab8f1
spl set id: 28ed2149-38d2-4062-8442-990a98a69cfc

Reported adverse events (FAERS/openFDA)#

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