Burn Relief
FDA Label NDC 63868-784

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Quality Choice for the product Burn Relief (NDC 63868-784). 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, when using this product, keep out of reach of the children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient                            Purpose

Lidocaine 0.5%                               External analgesic

Uses

Temporarily relieves pain and itching due to

• sunburn • minor burns • minor cuts • scrapes

• insect bites • minor skin irritation

Warnings

For external use only

When Using This Product

  • keep out of your eyes
  • use only as directed
  • do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120F.

Keep Out Of Reach Of The Children

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

Directions

• shake well
• 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

• to apply to face, spray into palm of hand and gently apply

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Carbomer, Diazolidinyl Urea, Disodium Cocoamphodipropionate, Disodium EDTA, Glycerin, Methylparaben, Propylene Glycol, Propylparaben, SD Alcohol 40, Simethicone, Tocopheryl Acetate, Triethanolamine

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