Burn Cream

Product NDC
58228-7080
11-digit product format
582287080
Labeler code
58228
Product ID
58228-7080_5dc00980-1217-3bbd-e063-6294a90a0a02
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride, Lidocaine HCI
Dosage form
CREAM
Route
TOPICAL
Labeler
Prostat First Aid
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-13
Substance
BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE
Active strength
.0013; .005 g/g; g/g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Burn Cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.0013 g/g
LIDOCAINE HYDROCHLORIDE.005 g/g

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 91 of 114 · 2,270 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isopropyl Rubbing Alcohol 70%ISOPROPYL ALCOHOLNew Pride Corpf0f223b9-fa98-f118-e053-2a95a90a1ac72024-12-19WarningsExact identifier
application number: M003
ISOPROPYL RUBBING ALCOHOL 70% WITH WINTERGREENISOPROPYL ALCOHOLHome Smart Products3c32b817-39fa-4801-9f40-6073b3e188552024-12-19WarningsExact identifier
application number: M003
ISOPROPYL RUBBING ALCOHOL 99% WITH WINTERGREENISOPROPYL ALCOHOLHome Smart Productsd196bef3-625a-b7d5-e053-2995a90afe6c2024-12-19WarningsExact identifier
application number: M003
Isopropyl Rubbing Alcohol 50%ISOPROPYL ALCOHOLHome Smart Productscfe4fca2-bb20-4ab3-b304-32d9ba0451f62024-12-19WarningsExact identifier
application number: M003
Isopropyl Rubbing Alcohol 70%ISOPROPYL ALCOHOLHome Smart Products9cc0767c-b9aa-42c1-b183-a35f2560942b2024-12-19WarningsExact identifier
application number: M003
ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREENISOPROPYL ALCOHOLNew Pride Corpf159051c-27de-52a9-e053-2995a90aeb722024-12-19WarningsExact identifier
application number: M003
91% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREENISOPROPYL ALCOHOLNew Pride Corpf15a6843-78bd-223c-e053-2a95a90a20332024-12-19WarningsExact identifier
application number: M003
91% Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLNew Pride Corpf158ad51-b772-257f-e053-2a95a90a55582024-12-19WarningsExact identifier
application number: M003
ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREENISOPROPYL ALCOHOLHome Smart Productsce735a5f-0502-44ca-b2d6-db97ad0c01cb2024-12-19WarningsExact identifier
application number: M003
AMORAY 70% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREENISOPROPYL ALCOHOLMY IMPORT USA INC8e52e75f-717a-4829-b1aa-f35cf1981af82024-12-19WarningsExact identifier
application number: M003
91% Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLHome Smart Productsd1601184-c38c-79eb-e053-2a95a90aba502024-12-19WarningsExact identifier
application number: M003
germstar Original unscentedISOPROPYL ALCOHOLSoaptronic, LLCda14d588-a9f7-4796-a532-20156afc100f2024-12-19WarningsExact identifier
application number: M003
germstarONEETHYL ALCOHOLSoaptronic, LLCa6909a0f-de15-51e3-e053-2995a90ab34f2024-12-19WarningsExact identifier
application number: M003
germstarONE unscentedETHYL ALCOHOLSoaptronic, LLCa6a798bd-09cb-1853-e053-2995a90a27f92024-12-19WarningsExact identifier
application number: M003
germstarCitrusETHYL ALCOHOLSoaptronic, LLC779abef7-53ff-47c3-b7e6-27570eb055b32024-12-19WarningsExact identifier
application number: M003
germstarGelETHYL ALCOHOLSoaptronic, LLCb5fd6c3c-d452-74e6-e053-2995a90a90902024-12-19WarningsExact identifier
application number: M003
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLJell Pharmaceuticals Pvt. Ltd.cd98812b-017a-2cd2-e053-2a95a90a38ce2024-12-18WarningsExact identifier
application number: M003
Isopropyl Rubbing Alcohol 50%ISOPROPYL ALCOHOLMY IMPORTS LLCd4d72406-067d-1f67-e053-2995a90a1a9f2024-12-18WarningsExact identifier
application number: M003
AMORAY 70% ISOPROPYL RUBBING ALCOHOLISOPROPYL ALCOHOLMY IMPORT USA INC7114b527-106b-4629-867c-63dba13635a22024-12-18WarningsExact identifier
application number: M003
AMERICAN REDCROSS 70% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREENISOPROPYL ALCOHOLMY IMPORTS USA LLCd4d7e7f8-7c8a-2b51-e053-2995a90a63d02024-12-18WarningsExact identifier
application number: M003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58228-7080-15822870800125 PACKET in 1 BOX (58228-7080-1) / .9 g in 1 PACKET25 packet2026-01-13NoNoCurrent