Publix Burn Relief
FDA Label NDC 56062-701

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Publix Super Markets Inc for the product Publix Burn Relief (NDC 56062-701). 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, otc - do not use, when using this product, stop use and ask a doctor if, 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 Ingredient

Lidocaine HCL 0.50%

Purpose

Topical Anesthetic

Uses

  • temporary relief of pain and itching
  • helps relieve and soothes pain from sunburn, minor burns,cuts,scrapes, skin irritations and inspect bites

Warnings

For external use only

Otc - Do Not Use

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

When Using This Product

  • avoid contact with eyes.

Stop Use And Ask A Doctor If

  • condition worsens or 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 get medical help or contact 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: do not use, ask a doctor

Inactive Ingredients

Water, Propylene Glycol, Glycerin, Isopropyl Alcohol, Triethanolamine, Polysorbate 80, Carbomer, Aloe Barbadensis Leaf Juice, Menthol, Disodium EDTA, Diazolidinyl Urea, Yellow 5, Blue 1.

Principal Display Panel

PublixburnreilefALOE VERA GELCOOLS AND RELIEVES SUNBURN PAIN WITH LIDOCAINENET WT 8 OZ( 227g)

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