FDA.reportPublic FDA data

ProStat First Aid Burn Cream

Manufacturer
Prostat First Aid | Trifecta Pharmaceuticals USA LLC
Effective date
2026-10-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-10-16 01:02:22

Label at a glance#

ProductBurn Cream
Active ingredientBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE
Label structure14 sections

Indications and uses

Temporary Relief of pain associated with minor cuts, scrapes and burns. Helps protect against harmful bacteria.

Dosage and administration

Clean the affected area Apply a small amount not more than 3 times daily May be covered with a sterile bandage

Storage and handling

Store in cool dry area 15° to 25°C (59° to 77°F). tamper evident sealed packets do not use any opened or torn packets

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCL 0.5%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

First Aid Antiseptic

Uses

INDICATIONS & USAGE SECTION

Temporary Relief of pain associated with minor cuts, scrapes and burns.

Helps protect against harmful bacteria.

Warnings

WARNINGS SECTION

For external Use Only

Do not use

  • in eyes
  • in large quantities
  • over raw or blistered areas, or on deep puncture wounds, animal bites, or serious burns
  • for more than one week unless directed by a doctor

Directions

DOSAGE & ADMINISTRATION SECTION

  • Clean the affected area
  • Apply a small amount not more than 3 times daily
  • May be covered with a sterile bandage

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe barbadensis leaf juice, Cetearyl alcohol, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl stearate,PEG-100 stearate, Maltodextrin, Mineral oil, Phenoxyethanol, Propylene glycol, purified water, stearic acid, Sodium Hydroxide

Questions

OTC - QUESTIONS SECTION

Questions

Call 1-888-900-2920

Monday - Friday 8AM - 4PM PST

Storage Information

STORAGE AND HANDLING SECTION

  • Store in cool dry area 15° to 25°C (59° to 77°F).
  • tamper evident sealed packets
  • do not use any opened or torn packets

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center immediately.

Other Information

SPL UNCLASSIFIED SECTION

Manufactured for Front Line Safety

La Verne, CA 91750

Part No 2044

OTC - PURPOSE SECTION

First Aid Antiseptic

PACKAGING

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FL 2044 TRI FIRST AID BURN CREAM 0.9G 25PK BOX 123025 CDERFL 2044 TRI FIRST AID BURN CREAM 0.9G 25PK BOX 123025 CDER

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130814889014887GTIN-13: 0814889014887
EAN-13: 0814889014887
GTIN-12: 814889014887
UPC-A: 814889014887
GTIN storage (14 digits): 00814889014887		FL 2044 TRI FIRST AID BURN CREAM 0.9G 25PK BOX 123025 CDER.jpg

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58228-708058228-7080-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
GLYCERYL STEARATE/PEG-100 STEARATERD25J5V947IACT
WATER059QF0KO0RIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE VERA LEAFZY81Z83H0XIACT
SODIUM HYDROXIDE55X04QC32IIACT
MALTODEXTRIN7CVR7L4A2DIACT
MINERAL OILT5L8T28FGPIACT
PHENOXYETHANOLHIE492ZZ3TIACT
STEARIC ACID4ELV7Z65APIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL STEARATE230OU9XXE4IACT

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 41 · 813 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
North Woods Derma Foam Hand SanitizerBENZALKONIUM CHLORIDESuperior Chemical Corporationad51a175-2b91-fd14-e053-2995a90ad54d2026-09-09WarningsName fallback
generic name: BENZALKONIUM CHLORIDE
Alcohol Free Foaming Hand SanitizerBENZALKONIUM CHLORIDEBetco Corporation, Ltd.7e038b0a-4813-4f4b-ad66-0584d75a064f2026-09-09WarningsName fallback
generic name: BENZALKONIUM CHLORIDE
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCITrifecta Pharmaceuticals USA LLCe9a9fc7c-31da-ea3f-e053-2a95a90a0eab2026-09-09WarningsName fallback
brand name: Burn Cream
Ultra Blue Antibacterial Foaming Skin CleanserBENZALKONIUM CHLORIDEBetco Corporation, Ltdaa8f5b05-882d-d05a-e053-2995a90abaea2026-09-09WarningsName fallback
generic name: BENZALKONIUM CHLORIDE
Unscented NasalGuard Antiseptic TopicalBENZALKONIUM CHLORIDETRUTEK CORP.eb036e11-a28c-fdc0-e053-2a95a90a9cdb2026-09-02WarningsName fallback
generic name: BENZALKONIUM CHLORIDE
NasalGuard Antiseptic Topical Cool MentholBENZALKONIUM CHLORIDETRUTEK CORP.e9fd3ef8-78ff-6c9f-e053-2a95a90a21a82026-09-01WarningsName fallback
generic name: BENZALKONIUM CHLORIDE
Swisher Advanced Antibacterial Foam HandsoapBENZALKONIUM CHLORIDEEcolab Inc.38bd6680-db95-424c-8e84-2e12c2388a732026-08-31WarningsName fallback
generic name: BENZALKONIUM CHLORIDE
MercurochromeBENZALKONIUM CHLORIDEVitamex USA, Corp21652b11-715d-0c54-e063-6294a90a88552026-08-26WarningsName fallback
generic name: BENZALKONIUM CHLORIDE
ClaravieBENZALKONIUM CHLORIDEGentell LLC59887af3-9b22-9664-e063-6294a90a57c62026-08-21WarningsName fallback
generic name: BENZALKONIUM CHLORIDE
Family Beauty Antibacterial Hand WipesBENZALKONIUM CHLORIDEZhejiang Bright Care Co., Ltd.6ff604f7-4011-4f0e-aa2d-a46e1a973d132026-08-21WarningsName fallback
generic name: BENZALKONIUM CHLORIDE
Softsoap Antibacterial Clean and Protect Cool SplashBENZALKONIUM CHLORIDECOLGATE PALMOLIVE COMPANY7d48e018-0874-4bbf-a95e-dc21702406c12026-08-20WarningsName fallback
generic name: BENZALKONIUM CHLORIDE
Refresh AntiBac FOAMBENZALKONIUM CHLORIDESC Johnson Professional USA Inc.884d1c8c-5643-423e-8ed4-d2ef38f8af732026-08-13WarningsName fallback
generic name: BENZALKONIUM CHLORIDE
Antibacterial Hand White Tea and EucalyptusBENZALKONIUM CHLORIDEUpLift Brands LLCff075334-501e-4f71-a563-9581a495a67b2026-08-11Warnings, Adverse reactionsName fallback
generic name: BENZALKONIUM CHLORIDE
Benzalkonium chlorideBENZALKONIUM CHLORIDENice-Pak Products, LLCe368e7b8-9695-4dd8-a49b-8c17c24c7f512026-08-10Warnings, Adverse reactionsName fallback
generic name: BENZALKONIUM CHLORIDE
antibacterial wipes 01BENZALKONIUM CHLORIDECosmuses Cosmetics (Ningbo) Co., Ltd.585dec39-ccb8-d2ba-e063-6394a90aec0f2026-08-06WarningsName fallback
generic name: BENZALKONIUM CHLORIDE
Giant EagleBENZALKONIUM CHLORIDEApollo Health and Beauty Care4d2aecfb-8865-bf54-e063-6394a90aec632026-08-05WarningsName fallback
generic name: BENZALKONIUM CHLORIDE
Wish Sanitizing Hand WipesBENZALKONIUM CHLORIDEZhejiang Bright Care Co., Ltd.c81c0924-bb01-4fa2-b933-8777358e45e72026-08-05WarningsName fallback
generic name: BENZALKONIUM CHLORIDE
Medi-First Antiseptic WipesBENZALKONIUM CHLORIDEUnifirst First Aid Corporationd31fe110-6d75-bf15-e053-2a95a90a86942026-08-03WarningsName fallback
generic name: BENZALKONIUM CHLORIDE
Zoono Hand SanitizerBENZALKONIUM CHLORIDEZoono Holdings USAb48c9a16-5027-1fdb-e053-2a95a90a54892026-07-31WarningsName fallback
generic name: BENZALKONIUM CHLORIDE
Zoono Wound CleanserBENZALKONIUM CHLORIDEZoono Holdings USA LLC41fae81e-a2f5-1c07-e054-00144ff8d46c2026-07-31WarningsName fallback
generic name: BENZALKONIUM CHLORIDE

Reported adverse events (FAERS/openFDA)#

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