FDA.reportPublic FDA data

NORTH Antiseptic Pump Spray

Manufacturer
North Safety Products, LLC. | Dixon Investments, Inc.
Effective date
2014-05-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:39:18

Label at a glance#

ProductNORTH Antiseptic First Aid
Active ingredientLIDOCAINE, BENZALKONIUM CHLORIDE
Label structure9 sections

Indications and uses

treatment of minor cuts, scratches and burns pain relief helps prevent infection soothes itching

Dosage and administration

Hold 4-6 inches from surface Spray area until wet

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.14%
Lidocaine 2.5%

Purpose

OTC - PURPOSE SECTION

Topical Antiseptic
Topical Anesthetic

Uses

INDICATIONS & USAGE SECTION

  • treatment of minor cuts, scratches and burns
  • pain relief
  • helps prevent infection
  • soothes itching

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • in eyes or near mucous membranes
  • serious burns
  • deep puncture wounds
  • for a prolonged period of time

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation, redness, or swelling increases
  • rash or infection occurs

Directions

DOSAGE & ADMINISTRATION SECTION

  • Hold 4-6 inches from surface
  • Spray area until wet

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Isopropyl Alcohol, Water

Principal Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1537434benzalkonium Cl 0.14 % / lidocaine 2.5 % Topical SprayPSN2
1537434benzalkonium chloride 1.4 MG/ML / lidocaine 25 MG/ML Topical SpraySCD2
1537434benzalkonium Cl 0.14 % / lidocaine 2.5 % Topical SpraySY2

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0498-0016-102019-11-27C16284748780-19855e2a2-36f3-60a7-e053-dbdaa90a05bdNORTH Antiseptic Pump Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0498-0016-10NORTH Antiseptic First Aid60 mL in 1 BOTTLE, SPRAYSPRAY, METERED602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0498-0016NORTH ANTISEPTIC FIRST AID (BENZALKONIUM CHLORIDE AND LIDOCAINE) SPRAY, METERED [NORTH SAFETY PRODUCTS, LLC.]2Legacy NDC, 1 package rows20140516_2ab9530e-fdfa-4ca1-afbe-a3787462371c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W72
LIDOCAINEACTIVE INGREDIENT98PI2009872
BENZALKONIUMACTIVE MOIETY7N6JUD5X6Y2
LIDOCAINEACTIVE MOIETY98PI2009872
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M4163022
WATERINACTIVE INGREDIENT059QF0KO0R2

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
0498-00160498-0016-10
52982-120

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
LIDOCAINE98PI200987ACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
ISOPROPYL ALCOHOLND2M416302IACT
WATER059QF0KO0RIACT

Source Document#

Source XML

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 · 9 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / AURICULAR (OTIC)6 mgExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302TABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii candidate
9 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
b73cf3ac-a97a-4cae-b0c5-d84687a8c6042ab9530e-fdfa-4ca1-afbe-a3787462371c2014-05-16WarningsExact identifier
spl id: b73cf3ac-a97a-4cae-b0c5-d84687a8c604
spl set id: 2ab9530e-fdfa-4ca1-afbe-a3787462371c

Reported adverse events (FAERS/openFDA)#

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