Active Ingredient
Lidocaine HCL 2.0%
Unishield First Aid Burn Spray
FDA Label NDC 49314-0002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Unishield for the product Unishield First Aid Burn (NDC 49314-0002). 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 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 over 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, hydroxypropyl methylcellulose, melaleuca alterniflia (tea tree) leaf oil, octoxynol 9, PEG-40 hydrogenated castor oil, phenoxyethanol, propylene glycol, triethanolamine, water
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Package Label - Principal Display Panel
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