MG217 Cooling Burn Spray

Manufacturer
Wisconsin Pharmacal Company
Effective date
2022-01-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:46:43

Label at a glance#

ProductMG217CoolingBurnSpray
Active ingredientBENZALKONIUM CHLORIDE, LIDOCAINE
Label structure9 sections

Indications and uses

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

Dosage and administration

Adults and children 2 years and older: clean the affected area, apply a small amount on the area 1 to 3 times daily. • may be covered with a sterile bandage • if bandaged, let dry first.

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

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

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Active ingredientsPurpose
Benzalkonium Chloride 0.13%First aid antiseptic
Lidocaine HCI USP 4%

Pain reliever

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have • deep puncture wounds • animal bites • serious burns

OTC - WHEN USING SECTION

When using this product • do not use in or near the eyes • do not apply over large areas of the body or in large quantities • do not apply over raw surfaces or blistered areas • avoid prolonged storage above 40C° (104°F)

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.

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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years and older: clean the affected area, apply a small amount on the area 1 to 3 times daily. • may be covered with a sterile bandage • if bandaged, let dry first.

Other information

OTHER SAFETY INFORMATION

• Do not puncture or incinerate • contents under pressure

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe barbadensis leaf extract (Aloe vera), Camphor, Deionized water, Propylene glycol

Questions or comments?

OTC - QUESTIONS SECTION

1-800-635-3696

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2047877benzalkonium chloride 0.13 % / lidocaine HCl 4 % Topical SprayPSN2
2047877benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 40 MG/ML Topical SpraySCD2
2047877benzalkonium chloride 0.13 % / lidocaine HCl 4 % Topical SpraySY2

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68093-7319-12024-01-30C16284748780-11030e365-325e-111a-e063-dadaa90a10e2MG217 Cooling Burn Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68093-7319-1MG217CoolingBurnSpray113 g in 1 CANSPRAY1132

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68093-7319MG217COOLINGBURNSPRAY (LIDOCAINE, BENZALKONIUM CHLORIDE) SPRAY [WISCONSIN PHARMACAL COMPANY]2Legacy NDC, 1 package rows20220114_a3501096-14db-4d1f-e053-2995a90a8947.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68093-731968093-7319-1

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

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
d57c1968-21f4-0c99-e053-2a95a90a37b6a3501096-14db-4d1f-e053-2995a90a89472022-01-13WarningsExact identifier
spl id: d57c1968-21f4-0c99-e053-2a95a90a37b6
spl set id: a3501096-14db-4d1f-e053-2995a90a8947

Reported adverse events (FAERS/openFDA)#

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