FDA.reportPublic FDA data

Cannabicool Pain Relieving Lidocaine Roll-On

Manufacturer
Market America, Inc. | A.I.G. Technologies, Inc.
Effective date
2022-01-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:47:02

Label at a glance#

ProductCannabicool Pain Relieving Lidocaine Roll-On
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure14 sections

Indications and uses

For the temporary relief of pain and itching.

Label contents#

Full prescribing information#

​Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl  4%

​Purpose

OTC - PURPOSE SECTION

Topical Anesthetic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain and itching.

WARNINGS SECTION

​For external use only.

SAFE HANDLING WARNING SECTION

​Flammable

Keep away from fire or open flame.

OTC - DO NOT USE SECTION

​Do not use

  • In large quantities, particularly over raw surfaces or blistered areas.
  • If you are allergic to any of the ingredients in this product.

OTC - WHEN USING SECTION

​When using this product

  • ​Avoid contact with eyes.
  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly.

OTC - STOP USE SECTION

​Stop use and ask a doctor if

  • Condition worsens.
  • Symptoms persist for more than 7 days or clear up and occur again within a few days.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

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

​Adults and children over 12 years:

  • ​Apply to affected area not more than 3 to 4 times daily.  If medicine comes in contact with hands, wash with soap and water.
  • For children under 12 years of age: ask a doctor.

OTHER SAFETY INFORMATION

​Other information

  • ​​Store tightly closed in a cool, dry place.

INACTIVE INGREDIENT SECTION

​Inactive ingredients

​​Aloe Barbadensis (Aloe Vera) Gel, Beta Caryophyllene, Boswellia Carterii Resin Extract, Calendula Officinalis Flower Extract, Cannabis Sativa Seed Oil, Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Glycerin, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis (Lemon Balm) Leaf Extract, Nigella Sativa (Black Cumin) Seed Oil, Silica, Tocopheryl Acetate, Triethanolamine, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 1Label 1Label 2Label 2

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76209-567-012025-01-30C16284748780-12cef2736-ad02-d83d-e063-dadaa90ab31fCannabicool Pain Relieving Lidocaine Roll-On

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76209-567-01Cannabicool Pain Relieving Lidocaine Roll-On88 g in 1 BOTTLE, DISPENSINGGEL882

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76209-567CANNABICOOL PAIN RELIEVING LIDOCAINE ROLL-ON (LIDOCAINE HCL) GEL [MARKET AMERICA, INC.]2Legacy NDC, 1 package rows20220115_cf327342-63af-464f-b284-1aa88016e9ad.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
76209-56776209-567-01

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
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
ALOE VERA LEAFZY81Z83H0XIACT
CARYOPHYLLENEBHW853AU9HIACT
FRANKINCENSER9XLF1R1WMIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)132584PQMOIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL ALCOHOLND2M416302IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
MELISSA OFFICINALIS LEAF50D2ZE9219IACT
NIGELLA SATIVA SEED OILCS4U38E731IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT

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
b3ce3eb0-5d8d-4539-a0d9-d6cc5df4f509cf327342-63af-464f-b284-1aa88016e9ad2022-01-14WarningsExact identifier
spl id: b3ce3eb0-5d8d-4539-a0d9-d6cc5df4f509
spl set id: cf327342-63af-464f-b284-1aa88016e9ad

Reported adverse events (FAERS/openFDA)#

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