FDA.reportPublic FDA data

ASYSTEM Radical Relief Gel Roll-On 300mg CBD

Manufacturer
Cosco International, Inc. | Cosco International, Inc
Effective date
2020-03-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:37:05

Label at a glance#

ProductASYSTEM Radical Relief Gel Roll-On 300mg CBD
Active ingredientMENTHOL, METHYL SALICYLATE
Label structure8 sections

Label contents#

Full prescribing information#

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

Menthol - 10% (External Analgesic)
Methyl Salicylate (NSAID) – 15% (External Analgesic)

OTC - PURPOSE SECTION

External Analgesic

INDICATIONS & USAGE SECTION

Temporarily relieves minor pain associated with sprains, bruises, muscle strains, arthritis, backache

WARNINGS:

WARNINGS SECTION

For External Use Only

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 immediately.

When using this product:

OTC - WHEN USING SECTION

Use only as directed.

Avoid contact with eyes.  Do not apply to wounds, damaged or irratated skin.

OTC - STOP USE SECTION

Stop usse and ask a doctor if:

  • Condition worsens
  • Severe skin irrataion occurs
  • Pain persists for more than 7 days
  • Pain ckears up and then recurs a few days later

DOSAGE & ADMINISTRATION SECTION

Directions:  Massage gel into the affected area using the cooling cryoshere until absorbed.

Re-apply 3 to 4 times a day.  Apply after a hot bath or shower for better absorption.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Alpha Tocopheryl Acetate (Vitamin E), Aminomethylpropanol, Arnica Montana Oil, Cannabidiol, Carbomer, Dimethyl Sulfoxide, Ethylhexylglycerin, Eucalyptus Oil, FD&C Blue No. 1, Maritime Pine, Glyceryl Monostearate, Glyceryl Stearate/PEG-100 Stearate, Magnesium Hydroxide, Phenoxyethanol, Polysorbate 80, Water

Questions?

OTC - QUESTIONS SECTION

info@asystem.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bottle labelbottle label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

carton labelcarton label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4d7a96d5-8256-4268-9a6c-25ea66d321feProduct name120180814

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52261-4901-02023-01-30C16284748780-1f386c64a-180a-0266-e053-dadaa90a7c1aASYSTEM Radical Relief Gel Roll-On 300mg CBD

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52261-4901-0ASYSTEM Radical Relief Gel Roll-On 300mg CBD1 in 1 CARTONGEL11
52261-4901-1ASYSTEM Radical Relief Gel Roll-On 300mg CBD0.075 kg in 1 BOTTLE, WITH APPLICATORGEL0.0751

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52261-4901ASYSTEM RADICAL RELIEF GEL ROLL-ON 300MG CBD (MENTHOL, METHYL SALICYLATE) GEL [COSCO INTERNATIONAL, INC.]1Legacy NDC, 2 package rows20210120_b612c5d4-8c94-436c-adc3-c78b79bb1c22.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52261-490152261-4901-1, 52261-4901-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
WATER059QF0KO0RIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
MARITIME PINE50JZ5Z98QYIACT
DIMETHYL SULFOXIDEYOW8V9698HIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
POLYSORBATE 806OZP39ZG8HIACT
CANNABIDIOL19GBJ60SN5IACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
GLYCERYL STEARATE/PEG-100 STEARATERD25J5V947IACT
EUCALYPTUS OIL2R04ONI662IACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
MAGNESIUM HYDROXIDENBZ3QY004SIACT
AMINOMETHYLPROPANOLLU49E6626QIACT

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
99954560-caf8-44e0-beef-c965bc20e0dbb612c5d4-8c94-436c-adc3-c78b79bb1c222020-03-19WarningsExact identifier
spl id: 99954560-caf8-44e0-beef-c965bc20e0db
spl set id: b612c5d4-8c94-436c-adc3-c78b79bb1c22

Reported adverse events (FAERS/openFDA)#

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