Cannabicool Pain Relieving Lidocaine Roll-on
FDA Label NDC 76209-567

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Market America, Inc. for the product Cannabicool Pain Relieving Lidocaine Roll-on (NDC 76209-567). 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 ​active ingredient, ​purpose, uses, warnings, safe handling warning, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

​Active Ingredient

Lidocaine HCl  4%

​Purpose

Topical Anesthetic

Uses

For the temporary relief of pain and itching.

Warnings

​For external use only.

Safe Handling Warning

​Flammable

Keep away from fire or open flame.

Otc - Do Not Use

​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

​When using this product

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

Otc - Stop Use

​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

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

Otc - Keep Out Of Reach Of Children

​Keep out of reach of children

​If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

​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

​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

* Please review the disclaimer below.