FDA.reportPublic FDA data

Genuine First Aid Antiseptic Spray

Manufacturer
Tender Corporation
Effective date
2016-06-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:46:21

Label at a glance#

ProductBenzocaine and Benzethonium
Active ingredientBENZETHONIUM CHLORIDE, BENZOCAINE
Label structure8 sections

Indications and uses

For temporary relief of pain, treatment and helps prevent infection in minor cuts and scrapes insect bites minor skin irritations

Dosage and administration

clean the affected area shake can well before using for adult institutional use only not for use on children hold 4-6 inches from surface and spray area until wet may be covered with sterile bandage. If bandaged, let dry first

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzethonium Chloride 0.2% w/w

Benzocaine 10% w/w

Purpose

OTC - PURPOSE SECTION

Topical Antiseptic

Topical Anesthetic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of pain, treatment and helps prevent infection in

  • minor cuts and scrapes
  • insect bites
  • minor skin irritations

Warnings

WARNINGS SECTION

For external use only

Flammable:

SAFE HANDLING WARNING SECTION

  • keep away from fire or flame
  • contents under pressure
  • do not puncture or incinerate container
  • do not expose to temperatures above 120°F

Do not use:

OTC - DO NOT USE SECTION

  • in or near mucous membranes
  • on serious burns
  • on deep puncture wounds
  • for a prolonged period of time
  • on a large portion of the body

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • redness, swelling, or irritation occurs
  • infection occurs
  • condition persists or worsens
  • symptoms persists for more than 7 days

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • clean the affected area
  • shake can well before using
  • for adult institutional use only
  • not for use on children
  • hold 4-6 inches from surface and spray area until wet
  • may be covered with sterile bandage. If bandaged, let dry first

Other Information

OTHER SAFETY INFORMATION

  • avoid inhaling
  • use only as directed
  • intentional misuse by deliberately concentrating and inhaling the contents may be harmful or fatal

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Dipropylene Glycol, Isobutane, n-Butane, Propane

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1192505benzethonium Cl 0.2 % / benzocaine 10 % Topical SprayPSN1
1192505benzethonium chloride 2 MG/ML / benzocaine 100 MG/ML Topical SpraySCD1
1192505benzethonium Cl 0.2 % / benzocaine 10 % 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
44224-3120-12023-01-30C16284748780-1f386c649-dfb8-0266-e053-dadaa90a7c1aGenuine First Aid Antiseptic Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44224-3120-1Benzocaine and Benzethonium85 g in 1 CANAEROSOL, SPRAY851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44224-3120BENZOCAINE AND BENZETHONIUM AEROSOL, SPRAY [TENDER CORPORATION]1Legacy NDC, 1 package rows20160623_35ce2638-6a77-41dd-e054-00144ff8d46c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44224-312044224-3120-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZETHONIUM CHLORIDEPH41D05744ACTIB
PROPANET75W9911L6IACT
DIPROPYLENE GLYCOLE107L85C40IACT
ISOBUTANEBXR49TP611IACT
BUTANE6LV4FOR43RIACT
BENZOCAINEU3RSY48JW5ACTIB

Source Document#

Source XML

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
35ce2638-6a78-41dd-e054-00144ff8d46c35ce2638-6a77-41dd-e054-00144ff8d46c2016-06-21WarningsExact identifier
spl id: 35ce2638-6a78-41dd-e054-00144ff8d46c
spl set id: 35ce2638-6a77-41dd-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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