Spravex

Manufacturer
Oncora Pharma, LLC
Effective date
2026-10-23
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-10-27 02:11:07

Label at a glance#

ProductSpravex
Active ingredientLIDOCAINE
Label structure8 sections

Indications and uses

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.

Dosage and administration

Spray the affected area in sufficient quantity 2 to 4 times daily as needed or as directed by a healthcare provider.

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

Spravex™ is a topical spray containing Lidocaine 4.12%.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

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

CONTRAINDICATIONS SECTION

Spravex™ is contraindicated in patients with known hypersensitivity to lidocaine or any component of the formulation.

WARNINGS

WARNINGS SECTION

For external use only. Avoid contact with eyes. If irritation, sensitivity, or infection occurs, discontinue use. Keep out of reach of children.

PRECAUTIONS

PRECAUTIONS SECTION

Use only as directed. Excessive application may result in increased systemic absorption of lidocaine.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Spray the affected area in sufficient quantity 2 to 4 times daily as needed or as directed by a healthcare provider.

REFERENCES

HOW SUPPLIED SECTION

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.]

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdp
pdp

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130854770327290GTIN-13: 0854770327290
EAN-13: 0854770327290
GTIN-12: 854770327290
UPC-A: 854770327290
GTIN storage (14 digits): 00854770327290
spravex-1.jpg

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85477-32785477-327-29

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22026-10-20daily-update2026-10-23 01:03:38

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.

Matched openFDA labels page 1 of 24 · 461 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LidocaineLIDOCAINEREMEDYREPACK INC.0748b9e3-1247-4eeb-8158-3d641b2ad85d2026-10-29Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE
Flarestop Hemorrhoid LidocaineLIDOCAINEChelsea Pharmacceuticals LLCb8a589f7-7131-4807-9bcb-84af3078e2582026-09-10WarningsName fallback
generic name: LIDOCAINE
Pain Relieving Lidocaine PatchLIDOCAINEYYBA CORPaf8c84fd-224c-72b3-e053-2a95a90a95682026-09-07WarningsName fallback
generic name: LIDOCAINE
Lidocaine CreamLIDOCAINEInvaDerm Corporation5a7273d1-1dbc-420e-e063-6294a90a86292026-09-01WarningsName fallback
generic name: LIDOCAINE
LIDOCAINELIDOCAINEREMEDYREPACK INC.dfef4554-aeb4-4bdf-9557-648d3e84af3c2026-08-31Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE
AnievaLCLIDOCAINEBlackstone Products, LLCddaba14c-10de-44e2-ae13-9217e20cb48e2026-08-29WarningsName fallback
generic name: LIDOCAINE
LidocaineLIDOCAINEA-S Medication Solutions3fbe48b5-128a-471c-8ecb-45e903b567402026-08-28Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE
LAIYINHE Numbing Cream Anorectal (Hemorrhoidal) CreamLIDOCAINEGuangzhou Hechuang Commercial Service Co.,Ltd.59f0fa16-5eb0-e6bb-e063-6294a90aacf52026-08-26WarningsName fallback
generic name: LIDOCAINE
CVS Pain ReliefLIDOCAINECVS Pharmacy4ecbc263-e0d4-18d5-e063-6294a90a72e92026-08-26WarningsName fallback
generic name: LIDOCAINE
CVS Pain Relief Lidocaine XLLIDOCAINECVS Pharmacy4aa286e3-e274-8095-e063-6394a90ae8712026-08-26WarningsName fallback
generic name: LIDOCAINE
LidocaineLIDOCAINESt. Mary's Medical Park Pharmacy9dc3059c-3a3d-5810-e053-2a95a90ab0ba2026-08-26Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE
Lidocaine Pain ReliefLIDOCAINECardinal Health, 110 dba LEADER025d508b-ec4f-466c-b3e8-ba9b18d07b462026-08-26WarningsName fallback
generic name: LIDOCAINE
Foot Pain Relief PadsLIDOCAINEShanghai Chuangshi Medical Technology (Group) Co., Ltd.5a18ff72-8a3e-5cdb-e063-6394a90a61622026-08-25WarningsName fallback
generic name: LIDOCAINE
LidocaineLIDOCAINEAmneal Pharmaceuticals LLC960f6d0a-82af-45e9-89d5-cea808004ebb2026-08-25Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE
Big Toe Joint Pain Relief PatchLIDOCAINEGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.59c8ff98-55c7-796d-e063-6394a90af73a2026-08-24WarningsName fallback
generic name: LIDOCAINE
Lidocaine Numbing CreamLIDOCAINEShanghai Chuangshi Medical Technology (Group) Co., Ltd.599b425a-0e96-76df-e063-6394a90a48ff2026-08-21WarningsName fallback
generic name: LIDOCAINE
Rugby PAIN RELIEF PATCHESLIDOCAINERUGBY LABORATORIESb34e40c8-a257-46cf-9399-f55df9b4102d2026-08-20WarningsName fallback
generic name: LIDOCAINE
Dr. Scholls Blister Pain Relief Complete KitLIDOCAINEScholl's Wellness Company LLC58c2b35c-e1ed-7ea8-e063-6294a90a14942026-08-19WarningsName fallback
generic name: LIDOCAINE
Dr. Scholls Blister Pain Relief Complete KitLIDOCAINEScholl's Wellness Company LLC585e740b-e4fa-d2aa-e063-6294a90a09822026-08-19WarningsName fallback
generic name: LIDOCAINE
Gembooxt Topical Numbing CreamLIDOCAINEGuangdong Quadrant Ecological Technology Co., Ltd.49951a3e-3b62-3d66-e063-6294a90a93602026-08-12WarningsName fallback
generic name: LIDOCAINE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.