FIRST AID & BURN CREAM

Manufacturer
HART Health
Effective date
2024-02-16
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:08:45

Label at a glance#

ProductFirst Aid and Burn
Active ingredientBENZALKONIUM CHLORIDE, LIDOCAINE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (in each gram):

Benzalkonium Chloride 0.13%

Lidocaine HCl 0.5%

OTC - PURPOSE SECTION

Purpose:

Topical Antiseptic

Topical Anesthetic

INDICATIONS & USAGE SECTION

Uses: Temporary relief of pain and to help prevent infection in

  • minor cuts
  • scrapes
  • burns

WARNINGS SECTION

Warnings: For external use only. See a doctor immediately for serious burns

OTC - DO NOT USE SECTION

Do not use:

  • in or near the eyes
  • over large portions of the body
  • in large quantities particularly over raw surfaces or blistered areas
  • longer than 7 days unless directed by a doctor
  • more than 1 to 3 times daily

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • serious burns
  • animal bites
  • deep or puncture wounds

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • condition lasts for more than 7 days
  • condition worsens
  • symptoms 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 right away. 1-800-222-1222

DOSAGE & ADMINISTRATION SECTION

Directions: do not use more than directed

Adults and children 2 years of age and over:

  • clean the affected area
  • apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
  • may be covered with a sterile bandage

Children under 2 years of age: ask a doctor

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Aloe Vera, Cetyl Alcohol, Diazolidinyl Urea, Edetate Disodium, Glycerin, Clyceryl Monostearate, Methylparaben, Mineral Oil, Polyethylene Glycol, Propylene Glycol, Propylparaben, Purified Water, Stearic Acid, Trolamine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FirstABurnv24f.jpgFirstABurnv24f.jpgFirstABurnv24f.jpgFirstABurnv24f.jpg

FirstABurnv24f.jpgFirstABurnv24f.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSN4
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCD4
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSY4

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
50332-0037-12024-02-16C16284748780-1d6a99b39-674a-a426-e053-dadaa90af4c2FIRST AID & BURN CREAM
50332-0037-22024-02-16C16284748780-1d6a99b39-674a-a426-e053-dadaa90af4c2FIRST AID & BURN CREAM
50332-0037-42024-02-16C16284748780-1d6a99b39-674a-a426-e053-dadaa90af4c2FIRST AID & BURN CREAM
50332-0037-62024-02-16C16284748780-1d6a99b39-674a-a426-e053-dadaa90af4c2FIRST AID & BURN CREAM
50332-0037-12024-01-30C16284748780-1d6a99b39-674a-a426-e053-dadaa90af4c2FIRST AID & BURN CREAM
50332-0037-22024-01-30C16284748780-1d6a99b39-674a-a426-e053-dadaa90af4c2FIRST AID & BURN CREAM
50332-0037-42024-01-30C16284748780-1d6a99b39-674a-a426-e053-dadaa90af4c2FIRST AID & BURN CREAM
50332-0037-62024-01-30C16284748780-1d6a99b39-674a-a426-e053-dadaa90af4c2FIRST AID & BURN CREAM
50332-0037-12022-11-28C16284748780-1d6a99b39-674a-a426-e053-dadaa90af4c2FIRST AID & BURN CREAM
50332-0037-22022-11-28C16284748780-1d6a99b39-674a-a426-e053-dadaa90af4c2FIRST AID & BURN CREAM
50332-0037-42022-11-28C16284748780-1d6a99b39-674a-a426-e053-dadaa90af4c2FIRST AID & BURN CREAM
50332-0037-62022-11-28C16284748780-1d6a99b39-674a-a426-e053-dadaa90af4c2FIRST AID & BURN CREAM
50332-0037-12022-01-28C16284748780-1d6a99b39-674a-a426-e053-dadaa90af4c2FIRST AID & BURN CREAM
50332-0037-22022-01-28C16284748780-1d6a99b39-674a-a426-e053-dadaa90af4c2FIRST AID & BURN CREAM
50332-0037-42022-01-28C16284748780-1d6a99b39-674a-a426-e053-dadaa90af4c2FIRST AID & BURN CREAM
50332-0037-62022-01-28C16284748780-1d6a99b39-674a-a426-e053-dadaa90af4c2FIRST AID & BURN CREAM

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50332-0037FIRST AID AND BURN (BENZALKONIUM CHLORIDE, LIDOCAINE) CREAM [HART HEALTH]4Current NDC, Legacy NDC20240217_f5746bba-9d7f-4691-b466-14985473bf14.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50332-003750332-0037-1, 50332-0037-6, 50332-0037-2, 50332-0037-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
First Aid and BurnBENZALKONIUM CHLORIDE, LIDOCAINEHART Healthf5746bba-9d7f-4691-b466-14985473bf142024-02-16WarningsExact identifier
ndc (package): 50332-0037-4
ndc (package): 50332-0037-2
ndc (package): 50332-0037-6
ndc (package): 50332-0037-1
ndc (product): 50332-0037
ndc11 (package): 50332003701
ndc11 (package): 50332003706
ndc11 (package): 50332003702
ndc11 (package): 50332003704
spl id: 94349edb-f001-44cb-82af-6b44cb352d84
spl set id: f5746bba-9d7f-4691-b466-14985473bf14

Reported adverse events (FAERS/openFDA)#

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