Description
LidoSpra™ is a topical spray containing Lidocaine 4.12%.
Lidospra Spray
FDA Label NDC 85477-325
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Oncora Pharma, Llc for the product Lidospra (NDC 85477-325). 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 description, indications and usage, contraindications, warnings, precautions, dosage and administration, references, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications And Usage
LidoSpra™ is indicated for topical analgesia and for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations, and rashes due to poison ivy, poison oak, or poison sumac, or as directed by a healthcare provider.
Contraindications
LidoSpra™ is contraindicated in patients with known hypersensitivity to lidocaine or any component of the formulation.
Warnings
For external use only. Avoid contact with eyes. If irritation, sensitivity, or infection occurs, discontinue use. Keep out of reach of children.
Precautions
Use only as directed. Excessive application may result in increased systemic absorption of lidocaine.
Dosage And Administration
Spray the affected area in sufficient quantity 2 to 4 times daily as needed or as directed by a healthcare provider.
References
LidoSpra™ (Lidocaine 4.12%) is supplied as a topical spray in a 30 mL (1 fl oz) container.
NDC 85477-325-29
Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.]
Principal Display Panel
Pdp
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