Burn Spray
FDA Label NDC 50332-0209

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hart Health for the product Burn (NDC 50332-0209). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients:

Lidocaine HCL 2%

Otc - Purpose

Purpose:

Topical Anesthetic

Indications & Usage

Uses:

Temporary pain relief of minor burns

Warnings

Warnings

For external use only

See a doctor immediately or serious burns

Otc - Do Not Use

Do not use

  • in or near the eyes
  • over large portions of the body
  • in large quantities particularly over raw surfaces or blistered areas
  • on serious burns
  • longer than 7 days unless directed by a doctor
  • on animal bites
  • on deep or puncture wounds

Otc - Stop Use

Stop use and ask a doctor if

  • condition lasts for more than 7 days
  • condition worsens
  • 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 a Poison Control Center right away. 1-800-222-1222

Dosage & Administration

Directions:

Adults and children 2 years of age and over:

  • clean the affected area
  • apply to the affected area not more than 3 to 4 times dailys
  • may be covered with a sterile bandage when dry

    • Children under 2 years of age: ask a doctor

Inactive Ingredient

Inactive Ingredients

aminomethyl propanol, glycerin, hydroxypropyl methylcellulose, melaleuca alterniflia (tea tree) leaf oil, octoxynol 9, PEG-40 hydrogenated castor oil, phenoxyethanol, propylene glycol, water 

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