FDA.reportPublic FDA data

First Aid Antiseptic

Manufacturer
Provision Medical | Safetec of America, Inc.
Effective date
2014-08-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:40:09

Label at a glance#

ProductFirst Aid Antiseptic
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

spray over cleaned affected area 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

Benzaikonium 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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if condition persists or gets worse

Directions

DOSAGE & ADMINISTRATION SECTION

  • spray over cleaned affected area 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

Treats Minor Cuts, Scrapes and Burns
Helps Prevent Infection and Relieves Pain

Package Not Child Resistant

2 fl. oz. (59.15ml)

Manufactured for

Provision Medical Products Palm Desert, CA 92211

Figure
Figure

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1245229benzalkonium chloride 0.1 % / benzocaine 5 % Topical SprayPSN1
1245229benzalkonium chloride 1 MG/ML / benzocaine 50 MG/ML Topical SpraySCD1
1245229benzalkonium Cl 0.1 % / benzocaine 5 % Topical SpraySY1

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
69103-3501-12020-01-31C16284748780-19d75b9d1-2256-f424-e053-dadaa90a57ce527232df-20d6-4e10-a478-e42a7a6dc20f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69103-3501-1First Aid Antiseptic0.0591 L in 1 BOTTLE, SPRAYSPRAY0.05911

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69103-3501FIRST AID ANTISEPTIC (BENZALKONIUM CHLORIDE AND BENZOCAINE) SPRAY [PROVISION MEDICAL]1Legacy NDC, 1 package rows20140904_527232df-20d6-4e10-a478-e42a7a6dc20f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
benzalkonium chlorideACTIVE INGREDIENTF5UM2KM3W71
benzocaineACTIVE INGREDIENTU3RSY48JW51
benzalkoniumACTIVE MOIETY7N6JUD5X6Y1
benzocaineACTIVE MOIETYU3RSY48JW51
isopropyl alcoholINACTIVE INGREDIENTND2M4163021
waterINACTIVE INGREDIENT059QF0KO0R1

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
69103-350169103-3501-1

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 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 ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact 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 ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact 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 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

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
ed3cb7fd-75d1-4b20-ad45-39fd5763a751527232df-20d6-4e10-a478-e42a7a6dc20f2014-08-29WarningsExact identifier
spl id: ed3cb7fd-75d1-4b20-ad45-39fd5763a751
spl set id: 527232df-20d6-4e10-a478-e42a7a6dc20f

Reported adverse events (FAERS/openFDA)#

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