LevigoSP

Manufacturer
Topicare Management, LLC | Wisconsin Pharmacal Company, LLC
Effective date
2018-08-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:56:33

Label at a glance#

ProductLevigoSP
Active ingredientBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE
Label structure14 sections

Storage and handling

Protect from excessive heat.

Label contents#

Full prescribing information#

Description

DESCRIPTION SECTION

LevigoSP is a Lidocaine HCL 2.5% and Benzalkonium Chloride 0.13% topical anesthetic spray indicated to temporarily relieve minor pain.

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCL 2.5% --- Pain Reliever

Benzalkonium Chloride 0.13% --- First Aid Antiseptic

Purpose

OTC - PURPOSE SECTION

For the temporary relief of minor pain or discomfort associated with minor: cuts, scrapes, burns, sunburn, skin irritations. First aid to prevent bacterial contamination or skin infections.

Warnings

WARNINGS SECTION

For external use only.

Ask Doctor

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have: *deep or puncture wounds *animal bites *serious burns.

When Using This Product

OTC - WHEN USING SECTION

When using this product: *use only as directed *do not use in or near the eyes *do not apply over large areas of the body *do not apply over raw surfaces or blistered areas.

Stop Use

OTC - STOP USE SECTION

Stop use and ask a doctor if: *condition worsens *symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Indications & Usage

INDICATIONS & USAGE SECTION

Directions:

Adults and Children over 2 years: Clean the affected area, apply a small amount on the affected area 1 to 3 times daily. If bandaged, let dry first.

Children under 2 years: Ask a doctor.

Pregnant or breast feeding: Ask a doctor.

Dose & Administration

DOSAGE & ADMINISTRATION SECTION

Manufactured By:

Wisconsin Pharmacal Co.

1 Pharmacal Way

Jackson, WI 53037

Made in the U.S.A. of U.S. and imported materials.

Manufactured For:

Topicare Therapeutics

1925 Longmire Rd.

Bldg. 2

Conroe, TX 77304

Net Wt. 5 FL OZ (150Ml) bottle

Questions or Comments

OTC - QUESTIONS SECTION

For questions or comments, call 1-936-703-5474.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Camphor, Deionized water, Propylene Glycol

Storage & Handling

STORAGE AND HANDLING SECTION

Protect from excessive heat.

Package Label. Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

levigosplevigosp

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70112-155-052023-07-28C16284748780-10191ceaa-6833-198a-e063-dbdaa90aec3e67cb2d7f-47a0-c7e8-e053-2991aa0a1951

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70112-155-05LevigoSP150 mL in 1 BOTTLE, SPRAYSPRAY1502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70112-155LEVIGOSP (LIDOCAINE/BENZALKOIUM CHLORIDE SPRAY) SPRAY [TOPICARE MANAGEMENT, LLC]2Legacy NDC, 1 package rows20180809_67cb2d7f-47a0-c7e8-e053-2991aa0a1951.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70112-155-05ML - Milliliter70112-155b4e687b5-f725-4810-8f09-c600850791e912018-04-19

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70112-15570112-155-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
730382c5-b001-6914-e053-2991aa0a8a0d67cb2d7f-47a0-c7e8-e053-2991aa0a19512018-08-09WarningsExact identifier
spl id: 730382c5-b001-6914-e053-2991aa0a8a0d
spl set id: 67cb2d7f-47a0-c7e8-e053-2991aa0a1951

Reported adverse events (FAERS/openFDA)#

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