FDA.reportPublic FDA data

FIRST AID SPRAY

Manufacturer
HART Health
Effective date
2024-01-18
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:07:34

Label at a glance#

ProductFirst Aid
Active ingredientBENZALKONIUM CHLORIDE, BENZOCAINE
Label structure10 sections

Indications and uses

First aid to help protect against skin infection and for the temporary relief of pain and itching in minor cuts and scrapes bites skin irritation

Dosage and administration

clean affected area and spray 1 to 3 times daily may be covered with a sterile bandage Children under 2 years of age: ask a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.1%

Benzocaine 5.0%

Purpose

OTC - PURPOSE SECTION

Topical Antiseptic

Topical Anethetic

Uses

INDICATIONS & USAGE SECTION

First aid to help protect against skin infection and for the temporary relief of pain and itching in

  • minor cuts and scrapes
  • bites
  • skin irritation

Warnings

WARNINGS SECTION

For external use only.

Flammable, keep away from heat or flame

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
  • on deep or puncture wounds
  • on animal bites
  • on serious burns
  • longer than 7 days unless directed by a doctor

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days
  • 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

Directions

DOSAGE & ADMINISTRATION SECTION

  • clean affected area and spray 1 to 3 times daily
  • may be covered with a sterile bandage

Children under 2 years of age: ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Isopropyl Alcohol, Purified Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2717FirstAidv20f.jpg2717FirstAidv20f.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1245229benzalkonium chloride 0.1 % / benzocaine 5 % Topical SprayPSN5
1245229benzalkonium chloride 1 MG/ML / benzocaine 50 MG/ML Topical SpraySCD5
1245229benzalkonium Cl 0.1 % / benzocaine 5 % Topical SpraySY5

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50332-0212-12022-11-28C16284748780-1ba0f9c33-52e2-a910-e053-dadaa90a0b85FIRST AID SPRAY
50332-0212-12021-01-29C16284748780-1ba0f9c33-52e2-a910-e053-dadaa90a0b85FIRST AID SPRAY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50332-0212-1First Aid60 mg in 1 BOTTLE, SPRAYSPRAY605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50332-0212FIRST AID (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [HART HEALTH]5Current NDC, Legacy NDC, 1 package rows20240119_a6d258ed-6d6d-42f0-9994-6c2c4c3d0f4a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W71
BENZOCAINEACTIVE INGREDIENTU3RSY48JW51
BENZALKONIUMACTIVE MOIETY7N6JUD5X6Y1
BENZOCAINEACTIVE MOIETYU3RSY48JW51
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M4163021
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50332-021250332-0212-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
BENZOCAINEU3RSY48JW5ACTIB
ISOPROPYL ALCOHOLND2M416302IACT
WATER059QF0KO0RIACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 14 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii+route
14 equally ranked IID candidates

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 AidBENZALKONIUM CHLORIDE, BENZOCAINEHART Healtha6d258ed-6d6d-42f0-9994-6c2c4c3d0f4a2024-01-18WarningsExact identifier
ndc (package): 50332-0212-1
ndc (product): 50332-0212
ndc11 (package): 50332021201
spl id: 5c22153e-7546-4a44-8ccc-d18f26a1fb50
spl set id: a6d258ed-6d6d-42f0-9994-6c2c4c3d0f4a

Reported adverse events (FAERS/openFDA)#

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