FDA.reportPublic FDA data

Antiseptic

Manufacturer
Afassco Inc. | Safetec of America, Inc.
Effective date
2023-01-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:53:13

Label at a glance#

ProductAntiseptic
Active ingredientbenzalkonium chloride, benzocaine
Label structure9 sections

Indications and uses

First aid to help prevent infection and for temporary pain relief in minor cuts, scrapes and burns

Dosage and administration

clean affected area and spray 1 to 3 times daily may be covered with a sterile bandage children under 2 ask a doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.1%

Benzocaine 5.0%

Purpose

OTC - PURPOSE SECTION

First Aid Antiseptic

Topical Pain Relief

Uses

INDICATIONS & USAGE SECTION

First aid to help prevent infection and for temporary pain relief in minor cuts, scrapes and burns

Warnings

WARNINGS SECTION

For external use only.
Flammable keep away from fire or flame.

Do not use

OTC - DO NOT USE SECTION

  • near eyes or mucous membranes
  • on deep or puncture wounds, animal bites, or serious burns
  • over large areas of the body
  • more than one week unless directed by a doctor

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.

OTC - STOP USE SECTION

Stop use and ask doctor if condition persists or gets worse

Directions

DOSAGE & ADMINISTRATION SECTION

  • clean affected area and spray 1 to 3 times daily
  • may be covered with a sterile bandage
  • children under 2 ask a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

isopropyl alcohol, purified water

PRINCIPAL DISPLAY PANEL – bottle label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

First Aid
Antiseptic
Spray

Aids in Preventing Infections

Temporary Pain Relief
Fights Infection
Promotes Healing

#623 2 Fl. Oz. (59 mL)

Mfd. For
Afassco
MINDEN, NV 89423

Bottle labelBottle label

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1245229benzalkonium chloride 0.1 % / benzocaine 5 % Topical SprayPSN4
1245229benzalkonium chloride 1 MG/ML / benzocaine 50 MG/ML Topical SpraySCD4
1245229benzalkonium Cl 0.1 % / benzocaine 5 % Topical SpraySY4

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51532-5300-32025-01-30C16284748780-12cef2736-8df9-d83d-e063-dadaa90ab31f3eb119d8-59da-405c-a5f4-a025636d394a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51532-5300-3Antiseptic59 mL in 1 BOTTLE, SPRAYSPRAY594

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51532-5300ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [AFASSCO INC.]4Legacy NDC, 1 package rows20230113_3eb119d8-59da-405c-a5f4-a025636d394a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
benzalkonium chlorideACTIVE INGREDIENTF5UM2KM3W72
benzocaineACTIVE INGREDIENTU3RSY48JW52
benzalkoniumACTIVE MOIETY7N6JUD5X6Y2
benzocaineACTIVE MOIETYU3RSY48JW52
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
51532-530051532-5300-3

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

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 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 ALCOHOLND2M416302OIL / AURICULAR (OTIC)6 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 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 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
f5940692-ef5c-492d-9d0b-c8c477eebb503eb119d8-59da-405c-a5f4-a025636d394a2023-01-12WarningsExact identifier
spl id: f5940692-ef5c-492d-9d0b-c8c477eebb50
spl set id: 3eb119d8-59da-405c-a5f4-a025636d394a

Reported adverse events (FAERS/openFDA)#

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