2.0% Lidocaine Burn Spray
FDA Label NDC 52000-441
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Universal Distribution Center Llc for the product 2.0% Lidocaine Burn (NDC 52000-441). 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 drug facts, active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Lidocaine HCl 2.0%
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 area • 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.
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.
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
AMINOMETHYL PROPANOL, GLYCERIN, HYDROXYPROPYL METHYLCELLULOSE, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, OCTOXYNOL-9, PEG-40 HYDROGENATED CASTOR OIL, PHENOXYETHANOL, PROPYLENE GLYCOL, WATER
Packaging
2.0%lidocaineburn (52000441 1)
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