Fruit Of The Earth Aloe Vera Cool Blue Gel
FDA Label NDC 62217-200

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Fruit Of The Earth, Inc. for the product Fruit Of The Earth Aloe Vera Cool Blue (NDC 62217-200). 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 ingredients, purpose, uses, warnings, otc - do not use, otc - when using, otc - ask doctor, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Lidocaine 1.0% (as Lidocaine HCl)

Purpose

External Analgesic

Uses

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

Warnings

  • For External Use Only

Otc - Do Not Use

​Do not use ​in large quantities, particularly over raw surfaces or blistered areas

Otc - When Using

When using this product avoid contact with eyes. If contact occurs, rinse with water to remove.

Otc - Ask Doctor

Stop use and ask a doctor if

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

Otc - Keep Out Of Reach Of Children

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

Directions

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

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Isoceteth-20, Triethanolamine, Carbomer, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Benzophenone-4, Blue 1.

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