FDA.reportPublic FDA data

Antiseptic

Manufacturer
Safetec of America, Inc.
Effective date
2024-02-07
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:08:31

Label at a glance#

ProductAntiseptic
Active ingredientBENZALKONIUM CHLORIDE, BENZOCAINE
Label structure8 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 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 ifcondition persists or gets worse

Directions

DOSAGE & ADMINISTRATION SECTION

  • clean affected 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

NDC 61010-5300-0

Safetec

Cut & Scrape
Antiseptic Spray

For Temporary Pain
Relief and to Help
Prevent Infection in
Minor Cuts, Scrapes
and Abrasions.

2 fl. oz. (59.1ml)
Reorder no. 53000

PRINCIPAL DISPLAY PANEL – bottle label
PRINCIPAL DISPLAY PANEL – bottle label

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
61010-5300-02024-02-13C16284748780-11030e365-1e0c-111a-e063-dadaa90a10e261010-5300, Cut and Scrape Antiseptic
61010-5300-22024-02-13C16284748780-11030e365-1e0c-111a-e063-dadaa90a10e261010-5300, Cut and Scrape Antiseptic
61010-5300-02024-01-30C16284748780-11030e365-1e0c-111a-e063-dadaa90a10e261010-5300, Cut and Scrape Antiseptic
61010-5300-22024-01-30C16284748780-11030e365-1e0c-111a-e063-dadaa90a10e261010-5300, Cut and Scrape Antiseptic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61010-5300-0Antiseptic60 g in 1 BOTTLE, SPRAYSPRAY604
61010-5300-2Antiseptic90 g in 1 BOTTLE, SPRAYSPRAY904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61010-5300ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [SAFETEC OF AMERICA, INC.]4Current NDC, Legacy NDC, 2 package rows20240214_458e65f2-826d-4550-8c7d-17add2d7ba9a.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
61010-530061010-5300-2, 61010-5300-0

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
ISOPROPYL ALCOHOLND2M416302IACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
BENZOCAINEU3RSY48JW5ACTIB

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 · 21 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
isopropyl alcoholISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii+route
21 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route
21 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route
21 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii+route
21 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii+route
21 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii+route
21 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii+route
21 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii+route
21 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii+route
21 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii+route
21 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact identifier — unii+route
21 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii+route
21 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact identifier — unii+route
21 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii+route
21 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii+route
21 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii+route
21 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii+route
21 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii+route
21 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact identifier — unii+route
21 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route
21 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii+route
21 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
AntisepticBENZALKONIUM CHLORIDE, BENZOCAINESafetec of America, Inc.458e65f2-826d-4550-8c7d-17add2d7ba9a2024-02-07WarningsExact identifier
ndc (package): 61010-5300-2
ndc (package): 61010-5300-0
ndc (product): 61010-5300
ndc11 (package): 61010530000
ndc11 (package): 61010530002
spl id: 10d37ff3-97c6-9f55-e063-6294a90a656b
spl set id: 458e65f2-826d-4550-8c7d-17add2d7ba9a

Reported adverse events (FAERS/openFDA)#

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