Fruit Of The Earth Cool Blue Aloe Mist Continuous Spray
FDA Label NDC 62217-095

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 Cool Blue Aloe Mist Continuous (NDC 62217-095). 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, ​do not use, when using this product, stop use and ask a doctor if, 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% (as Lidocaine HCl)

Purpose

Topical 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

​Do Not Use

​in large quantities, particularly over raw surfaces or blistered areas

When Using This Product

  • Avoid sprying in eyes. Rinse with water to remove.
  • Do not puncture or incinerate. Contents under pressure.
  • do not store at temperatures above 120°F.

Stop Use And Ask A Doctor If

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

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; spray onto affected area not more than 3 to 4 times daily. Hold container 4 to 6 inches away from face from affected area to apply
  • Children under 2 years of age: ask a doctor.
  • To apply to the face, spray into hand and apply.

Inactive Ingredients

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

Package Label.Principal Display Panel

61332d3 (61332d3)

61332d3 (61332d3)

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