FDA.reportPublic FDA data

Your Logo Here Antiseptic Pump Spray

Manufacturer
Dixon Investments, Inc.
Effective date
2013-05-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:35:35

Label at a glance#

ProductYour Logo Here Antiseptic First Aid
Active ingredientLIDOCAINE, BENZALKONIUM CHLORIDE
Label structure9 sections

Indications and uses

Treatment of minor cuts and abrasions 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%

Purposes

OTC - PURPOSE SECTION

Topical Antiseptic
Topical Anesthetic

Uses

INDICATIONS & USAGE SECTION

Treatment of minor cuts and abrasions
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
For serious burns
Deep puncture wounds
For 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 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
52982-120-122019-11-27C16284748780-19855d018-dbe9-cd31-e053-dbdaa90ab51aYour Logo Here Antiseptic Pump Spray
52982-120-132019-11-27C16284748780-19855d018-dbe9-cd31-e053-dbdaa90ab51aYour Logo Here Antiseptic Pump Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52982-120-12Your Logo Here Antiseptic First Aid60 mL in 1 BOTTLE, SPRAYSPRAY, METERED603
52982-120-13Your Logo Here Antiseptic First Aid90 mL in 1 BOTTLE, SPRAYSPRAY, METERED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52982-120YOUR LOGO HERE ANTISEPTIC FIRST AID (BENZALKONIUM CHLORIDE AND LIDOCAINE) SPRAY, METERED [DIXON INVESTMENTS, INC.]3Legacy NDC, 2 package rows20130531_ecda79f9-1bfc-4890-b18e-9fbe0fec2b01.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W73
LIDOCAINEACTIVE INGREDIENT98PI2009873
BENZALKONIUMACTIVE MOIETY7N6JUD5X6Y3
LIDOCAINEACTIVE MOIETY98PI2009873
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M4163023
WATERINACTIVE INGREDIENT059QF0KO0R3

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
52982-12052982-120-13, 52982-120-12

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 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
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 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 ALCOHOLND2M416302GEL / TOPICAL75 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 ALCOHOLND2M416302TABLET, EXTENDED RELEASE / ORALNAExact 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
96b179c7-bc85-441a-a78d-774d787b1fccecda79f9-1bfc-4890-b18e-9fbe0fec2b012013-05-31WarningsExact identifier
spl id: 96b179c7-bc85-441a-a78d-774d787b1fcc
spl set id: ecda79f9-1bfc-4890-b18e-9fbe0fec2b01

Reported adverse events (FAERS/openFDA)#

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