Asystem Radical Relief Gel Roll-on 300mg Cbd
FDA Label NDC 52261-4901

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cosco International, Inc. for the product Asystem Radical Relief Gel Roll-on 300mg Cbd (NDC 52261-4901). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, otc - purpose, indications & usage, warnings:, otc - keep out of reach of children, when using this product:, otc - stop use, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

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

Otc - Purpose

External Analgesic

Indications & Usage

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

Warnings:

For External Use Only

Otc - Keep Out Of Reach Of Children

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

When Using This Product:

Use only as directed.

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

Otc - Stop Use

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

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:

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

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