Aeroburn Burn First Aid
FDA Label NDC 55305-116

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aero Healthcare, Llc. for the product Aeroburn Burn First Aid (NDC 55305-116). 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, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

Benzocaine 10% w/w
Benzethonium Chloride .2% w/w
Menthol .33% w/w

Purpose

Topical Anesthetic
Topical Antiseptic
Topical Anesthetic

Uses

For temporary relief of pain, treatment and helps prevent infection in

  • minor cuts and scrapes
  • insect bites
  • minor skin irritations
  • burns
  • sunburns

Warnings

For external use only

Flammable

  • keep away from fire or flame
  • contents under pressure
  • do not puncture or incinerate container
  • do not expose to temperatures above 120°F 

Do Not Use

  • in or near mucous membranes
  • on serious burns
  • on deep puncture wounds
  • for prolonged period of time
  • on a large portion of the body

Stop Use And Ask A Doctor If

  • redness, swelling, or irritation occurs
  • infection occurs
  • condition persists or worsens
  • symptoms persist for more than 7 days

Keep Out Of Reach Of Children.

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

Directions

  • clean the affected area
  • shake can well before using
  • for adult institutional use only
  • hold 4-6 inches from surface and spray area until wet
  • not for use on children 
  • may be covered with a sertile bandage. If bandaged, let dry first. 

Other Information

  • avoid inhaling
  • use only as directed
  • intentional misuse by deliberately concentrating and inhaling the contents may be harmful or fatal 

Inactive Ingredients

Dipropylene Glycol, Isobutane, n-Butane, Propane

Principal Display

Image Description (Burn)

Image Description (Burn)

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