Indications and uses
Nuvexa™ is indicated for topical analgesia as directed by a healthcare provider.
Nuvexa™ 2.8% Gel
- Manufacturer
- Oncora Pharma, LLC
- Effective date
- 2026-10-26
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 1
- Source
- daily-update
- Hydrated at
- 2026-10-30 01:03:40
Label at a glance#
ProductNuvexa
Active ingredientLIDOCAINE
Label structure8 sections
Dosage and administration
For topical use only. Apply to the affected area 3 to 4 times daily or as directed by a healthcare provider.
Label contents#
Full prescribing information#
DESCRIPTION
Nuvexa™ is a topical gel containing Lidocaine Hydrochloride 28 mg/g (2.8%).
INDICATIONS AND USAGE
Nuvexa™ is indicated for topical analgesia as directed by a healthcare provider.
CONTRAINDICATIONS
Nuvexa™ is contraindicated in patients with known hypersensitivity to lidocaine or any component of the formulation.
WARNINGS
For external use only. Not for ophthalmic use.
Avoid contact with eyes.
Excessive application may result in increased systemic absorption.
Keep out of reach of children.
OVERDOSAGE
Excessive topical application may result in increased systemic absorption of lidocaine. In the event of overdose, discontinue use and seek medical attention.
DOSAGE AND ADMINISTRATION
For topical use only.
Apply to the affected area 3 to 4 times daily or as directed by a healthcare provider.
HOW SUPPLIED
Nuvexa™ (Lidocaine Hydrochloride 28 mg/g) is supplied as a clear topical gel in a 3.5 oz (100 g) tube.
NDC 85477-0313-07
PRINCIPAL DISPLAY PANEL
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0844771313071 | GTIN-13: 0844771313071 EAN-13: 0844771313071 GTIN-12: 844771313071 UPC-A: 844771313071 GTIN storage (14 digits): 00844771313071 | nuvexa-1.jpg |
Products#
Every source-derived product name is available through these pages.
- Nuvexa
- Lidocaine 2.8
- LIDOCAINE
- WATER
- HYDROXYETHYLCELLULOSE
- PHENOXYETHANOL
- ETHYLHEXYLGLYCERIN
- SODIUM HYDROXIDE
- LACTIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 85477-313 | 85477-313-07 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| LIDOCAINE | 98PI200987 | ACTIB |
| WATER | 059QF0KO0R | IACT |
| HYDROXYETHYLCELLULOSE | T4V6TWG28D | IACT |
| PHENOXYETHANOL | HIE492ZZ3T | IACT |
| ETHYLHEXYLGLYCERIN | 147D247K3P | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| LACTIC ACID | 33X04XA5AT | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.