Active Ingredient
Lidocaine Hydrochloride 2%
Burn Ease Cooling Gel
FDA Label NDC 58228-2893
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Prostat First Aid Llc for the product Burn Ease Cooling (NDC 58228-2893). 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, use(s), 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.
Label Section Quick Index
Purpose
Topical Pain Relief
Use(S)
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 (1-800-222-1222) right away.
Directions
Apply an even layer of burn gel over cleaned affected area not more than 3-4 times daily
Not to be used on children under 12 years of age
Other Information
• store at 68-77F (20-25C)
- tamper evident sealed packets
- do not use any opened or torn packets
Inactive Ingredients
Aloe Barbadensis Leaf Juice, Aminomethyl propanol, Carbomer, Ethylhexylglycerin, Maltodextrin, Menthol, Polyethylene glycol, Phenoxyethanol, Tocopheryl Acetate, Water
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