Otc - Active Ingredient
Lidocaine hydrochloride 2%
Xeroburn Burn Gel
FDA Label NDC 67777-129
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dynarex Corporation for the product Xeroburn Burn Gel (NDC 67777-129). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Analgesic
Indications & Usage
■ For the temporary relief of pain associated with ■ minor burns ■ sunburn
■ Provides cooling pain relief
Warnings
For External Use Only
Otc - Do Not Use
Do not use
■ on wounds or damaged skin
■ in large quantities, particularly over raw surfaces or blistered areas
Otc - When Using
When using this product
■ avoid contact with the eyes
■ do not bandage tightly
Otc - Stop Use
Stop use and ask a doctor if
■ condition worsens
■ symptoms persist for more than 7 days
■ symptoms clear up and occur again within a few days
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
■ Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily
■ Children under 2 years of age: Consult a doctor
Inactive Ingredient
AACP, Carbomer, Glycerin, Imidazolidinyl urea, Methylparaben, Propylene glycol, Propylparaben, Purified water, Tea tree leaf oil, Triethanolamine
Package Label.Principal Display Panel
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