Active Ingredient
Lidocaine HCl 2.0%
Aeroburn Spray
FDA Label NDC 55305-145
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 Us Llc for the product Aeroburn (NDC 55305-145). 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, do not use, stop use and ask a doctor, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical pain relief
Uses
Temporary pain relief associated with minor burns
Warnings
For external use only.
Do Not Use
in large quantities, particularly over raw or blistered areas; near eyes, if this happens rinse thoroughly with water
Stop Use And Ask A Doctor
if the condition worsens or persists for more than 7 days or clears up and returns.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Spray an even layer of burn spray over cleaned affected area not more than 3-4 times daily. Not to be used on children under 12 years of age.
Inactive Ingredients
Glycerin, Tea Tree Oil, Aminomethylpropanol, Hypromellose, Unspecified, Octoxynol-9, Polyoxyl 40 Hydrogenated Castor Oil, Phenoxyethanol, Propylene Glycol, Water
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