FDA.reportPublic FDA data

North First Aid Antiseptic Spray

Manufacturer
North Safety Products | Dixon Investments
Effective date
2013-04-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:35:07

Label at a glance#

ProductNorth First Aid Antiseptic
Active ingredientBENZOCAINE, BENZETHONIUM CHLORIDE
Label structure8 sections

Indications and uses

for temporary relief of pain and itching and helps protect against infection in: minor cuts and scrapes insect bites minor skin irritations

Dosage and administration

clean the affected area shake can well before using hold 4 - 6 inches from surface and spray area until wet may be covered with a sterile bandage, if bandaged let dry first for adult institutional use only not intended for use on children

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzethonium chloride 0.02% w/w

Benzocaine 10% w/w

Purpose

OTC - PURPOSE SECTION

Topical antiseptic

Topical anesthetic

Uses

INDICATIONS & USAGE SECTION

for temporary relief of pain and itching and helps protect against infection in:

  • minor cuts and scrapes
  • insect bites
  • minor skin irritations

Warnings

WARNINGS SECTION

For external use only

Flammable

  • keep away from fire or flame
  • contents under pressure
  • do not puncture or incinerate container
  • do not expose to temperatures above 120o F

Do not use

OTC - DO NOT USE SECTION

  • in or near the eyes or other mucus membranes
  • in case of serious burns
  • in case of deep or puncture wounds
  • for prolonged period of time
  • on large portion of the body

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens or symptoms persist for more than 7 days
  • condition clears up and recurs within a few days
  • redness, swelling or irritation occurs

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • clean the affected area
  • shake can well before using
  • hold 4 - 6 inches from surface and spray area until wet
  • may be covered with a sterile bandage, if bandaged let dry first
  • for adult institutional use only
  • not intended for use on children

Other information

SPL UNCLASSIFIED SECTION

  • avoid inhaling
  • use only as directed
  • intentional misuse by deliberately concentrating or inhaling the contents may be harmful or fatal

Inactive ingredients

INACTIVE INGREDIENT SECTION

dipropylene glycol, isobutane, n-butane, propane

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of pdpimage of pdpEnter section text here

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
0498-0015-402019-11-27C16284748780-19855d018-e675-cd31-e053-dbdaa90ab51aNorth First Aid Antiseptic Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0498-0015-40North First Aid Antiseptic85 g in 1 CANSPRAY853

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0498-0015NORTH FIRST AID ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [NORTH SAFETY PRODUCTS]3Legacy NDC, 1 package rows20130407_109e0046-eb93-445b-a224-af897a5a0793.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZETHONIUM CHLORIDEACTIVE INGREDIENTPH41D057443
BENZOCAINEACTIVE INGREDIENTU3RSY48JW53
BENZETHONIUMACTIVE MOIETY1VU15B70BP3
BENZOCAINEACTIVE MOIETYU3RSY48JW53
BUTANEINACTIVE INGREDIENT6LV4FOR43R3
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C403
ISOBUTANEINACTIVE INGREDIENTBXR49TP6113
PROPANEINACTIVE INGREDIENTT75W9911L63

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
0498-00150498-0015-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOCAINEU3RSY48JW5ACTIB
BENZETHONIUM CHLORIDEPH41D05744ACTIB
DIPROPYLENE GLYCOLE107L85C40IACT
ISOBUTANEBXR49TP611IACT
BUTANE6LV4FOR43RIACT
PROPANET75W9911L6IACT

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 · 12 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PROPANEPROPANET75W9911L6AEROSOL, FOAM / TOPICAL55 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
ISOBUTANEISOBUTANEBXR49TP611AEROSOL / TOPICAL4484 mgExact identifier — unii candidate
4 equally ranked IID candidates
PROPANEPROPANET75W9911L6AEROSOL, FOAM / RECTAL9 mgExact identifier — unii candidate
2 equally ranked IID candidates
ISOBUTANEISOBUTANEBXR49TP611AEROSOL, FOAM / TOPICAL18 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40FILM, EXTENDED RELEASE / BUCCAL30 mgExact identifier — unii candidate
3 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40FILM, EXTENDED RELEASE / TRANSDERMAL296 mgExact identifier — unii candidate
3 equally ranked IID candidates
BUTANEBUTANE6LV4FOR43RAEROSOL / TOPICALNAExact identifier — unii candidate
3 equally ranked IID candidates
ISOBUTANEISOBUTANEBXR49TP611AEROSOL, FOAM / RECTAL142 mgExact identifier — unii candidate
4 equally ranked IID candidates
BUTANEBUTANE6LV4FOR43RAEROSOL, FOAM / RECTAL12 mgExact identifier — unii candidate
3 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40SYSTEM / TRANSDERMAL6 mgExact identifier — unii candidate
3 equally ranked IID candidates
ISOBUTANEISOBUTANEBXR49TP611AEROSOL, SPRAY / TOPICAL4484 mgExact identifier — unii candidate
4 equally ranked IID candidates
BUTANEBUTANE6LV4FOR43RAEROSOL, FOAM / TOPICAL27 %w/wExact identifier — unii candidate
3 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
4a402e6c-8fae-479e-962f-6a4922fa2a81109e0046-eb93-445b-a224-af897a5a07932013-04-06WarningsExact identifier
spl id: 4a402e6c-8fae-479e-962f-6a4922fa2a81
spl set id: 109e0046-eb93-445b-a224-af897a5a0793

Reported adverse events (FAERS/openFDA)#

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