FDA.reportPublic FDA data

Isopropyl Alcohol with Benzocaine

Manufacturer
McKesson Corporation | Shanghai Yinjing Medical Supplies Co., Ltd
Effective date
2012-06-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:32:10

Label at a glance#

ProductIsopropyl Alcohol with Benzocaine
Active ingredientIsopropyl Alcohol, Benzocaine
Label structure10 sections

Dosage and administration

Adults and children 2 years of age or older Apply as needed to clean intended area. For insect bites, skin irritations, minor burns and sunburn. Apply to affected site no more than 3 to 4 times daily. Discard after single use.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts                  FigureFigure

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol, 70% v/v

Benzocaine, 6%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Topical Anesthetic

Use

INDICATIONS & USAGE SECTION

For preparation of the skin prior to injection

  • For insect bites, skin irritations, minor burns and sunburn

Warnings

WARNINGS SECTION

For external use only

  • Flammable, keep away from fire or flame

OTC - DO NOT USE SECTION

  • Do not use: with electrocautery or in eyes

OTC - STOP USE SECTION

  • Stop use: if redness or irritation develops, if condition continues for more than 72 hours consult a physician.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach from children: If swallowed, get medical attention or call Poison Control immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

SPL UNCLASSIFIED SECTION

Adults and children 2 years of age or older Apply as needed to clean intended area.

SPL UNCLASSIFIED SECTION

For insect bites, skin irritations, minor burns and sunburn. Apply to affected site no more than 3 to 4 times daily. Discard after single use.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

30% purified water.

Other Information

SPL UNCLASSIFIED SECTION

Do not use to clean or disinfect medical devices or on hard surfaces. Store at room temperature: 59°-86°F (15°-30°C).

McKESSON

Distribute By McKesson
One Post Street, San Francisco, CA 94104
Money Back Guarantee
Please visit us at www.sunmarkbrand.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel – Box Label

sunmark®

NDC 49348-974-10

sterile alcohol prep pads
with benzocaine
Antiseptic/Anesthetic

Safe and easy to use

70% Isopropyl Alcohol

100 INDIVIDUALLY WRAPPED FOIL PACKETS

1.18 X 1.18 IN (3 X 3 CM)

Principal Display Panel – Box Label
Principal Display Panel – Box Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel – Packet Label

sunmark®

sterile alcohol prep pad
with benzocaine
Antiseptic/Anesthetic

70% Isopropyl Alcohol
6% Benzocaine

Contains 1 Prep Pad

Distributed By McKesson
One Post Street, San Francisco, CA 94104

Money Back Guarantee
Please visit us at www.sunmarkbrands.com

Made in China

Principal Display Panel – Packet Label
Principal Display Panel – Packet Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
809206benzocaine 6 % / isopropyl alcohol 70 % Medicated PadPSN1
809206benzocaine 60 MG/ML / isopropyl alcohol 0.7 ML/ML Medicated PadSCD1
809206benzocaine 6 % / isopropyl alcohol 70 % Medicated PadSY1
809206benzocaine 6 % / isopropyl alcohol 70 % Topical SwabSY1

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130010939435446GTIN-13: 0010939435446
EAN-13: 0010939435446
GTIN-12: 010939435446
UPC-A: 010939435446
GTIN storage (14 digits): 00010939435446		sun01-0000-02.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49348-974-102020-01-31C16284748780-19d75b9d0-979f-f424-e053-dadaa90a57ce780c07fa-b77f-48a9-946f-b24478f9e5b3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49348-974-10Isopropyl Alcohol with Benzocaine.76 mL in 1 PACKETSWAB.761
49348-974-10Isopropyl Alcohol with Benzocaine100 in 1 BOXSWAB1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-974ISOPROPYL ALCOHOL WITH BENZOCAINE (ISOPROPYL ALCOHOL, BENZOCAINE) SWAB [MCKESSON CORPORATION]1Legacy NDC, 2 package rows20120601_780c07fa-b77f-48a9-946f-b24478f9e5b3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-974-10EA - Each49348-974b58f635b-fa8b-4be6-8fbb-7ded26e49a5012018-10-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BenzocaineACTIVE INGREDIENTU3RSY48JW51
Isopropyl AlcoholACTIVE INGREDIENTND2M4163021
BenzocaineACTIVE MOIETYU3RSY48JW51
Isopropyl AlcoholACTIVE MOIETYND2M4163021
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49348-97449348-974-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
Isopropyl AlcoholND2M416302ACTIB
BenzocaineU3RSY48JW5ACTIB
Water059QF0KO0RIACT

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
9b218a04-28ba-443f-a522-86c25a803cfa780c07fa-b77f-48a9-946f-b24478f9e5b32012-06-01WarningsExact identifier
spl id: 9b218a04-28ba-443f-a522-86c25a803cfa
spl set id: 780c07fa-b77f-48a9-946f-b24478f9e5b3

Reported adverse events (FAERS/openFDA)#

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