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Spravex (Xylocaine) Package Insert

Status:
Prescription (Rx) Facts
Strength:
41.2 mg/mL
Brand names:
Drug class:
Active ingredient:
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Source: FDA drug labeling via NLM DailyMed · About this document

Prescribing information (package insert) - Spravex

DESCRIPTION

Spravex™ is a topical spray containing Lidocaine 4.12%.

INDICATIONS AND USAGE

Spravex™ 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

Spravex™ 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

Spravex™ (Lidocaine 4.12%) is supplied as a topical spray in a 30 mL (1 fl oz) container.

NDC 85477-327-29

Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.]

About this document

Source: FDA drug labeling via NLM DailyMed · View the label on DailyMed

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Drug information for Spravex

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Amide Local Anesthetic, Antiarrhythmic
Active ingredient Lidocaine 41.2 mg/mL
Dosage form Spray
Route Topical
Marketing status not in the current FDA NDC Directory
Company (applicant) Oncora Pharma, LLC
FDA approval UNAPPROVED DRUG OTHERUnapproved drug
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
41.2 mg/mL – 30 ml in 1 bottle, spray NDC 85477-327-29

Source: FDA drug labeling via NLM DailyMed, data as of November 3, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.