First Degree Burn
FDA Label NDC 24330-111

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by The Akshay Wellness Group, Inc. for the product First Degree Burn (NDC 24330-111). 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, ask a physician before use if you have, stop use and ask a physician if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Benzocaine 20.0%

Triclosan 0.13%

Purpose

Pain relieving spray

First aid antiseptic

Uses

  • for temporary relief of pain and itching from minor burns, cuts and scrapes
  • first aid to help prevent infection in minor burns, cuts and scrapes

Warnings

For external use only.

Flammable: Do not use while smoking or near heat or flame.

Do Not Use

  • in the eyes
  • over large areas of the body

When Using This Product

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

Ask A Physician Before Use If You Have

  • serious burns
  • deep or puncture wounds
  • existing infection
  • animal bites

Stop Use And Ask A Physician If

  • conditions persist or worsen
  • rash or other allergic reaction develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • needed for longer than 1 week

Keep Out Of Reach Of 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: clean affected area, spray small amount of this product on the area, not more than 1 to 3 times daily
  • if bandaged, let dry first
  • children under 2 years of age: consult a physician
  • to apply to face, spray into palm of hand and gently apply

Inactive Ingredients

SD Alcohol 40, Propylene Glycol, Disopropyl Adipate, Tocopheryl Acetate (Vitamin E Acetate)

Questions Or Comments?

1-888-565-BURNCARE (565-2876)
Monday through Friday, 9am-5pm

Principal Display Panel

Maximum Pain Relief

First°Degree® Burn Spray

  • instant pain relief
  • helps prevent infection
  • cools burn on contact

    • Sprays at an angle!

    Burns Happen. Be Prepared.™

    Net Wt. 3 oz (85 g)

    Drug Facts Panel

    First Degree Burn Spray Bottle Label (8bbc5057 7e59 4b84 Ab30 B775b1a18dd3 01)

    First Degree Burn Spray Bottle Label (8bbc5057 7e59 4b84 Ab30 B775b1a18dd3 01)

    Bottle Label

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