FDA.reportPublic FDA data

Benzocaine

Manufacturer
Dynarex Corporation | Taizhou Kanglin Health Protection Products Co Ltd
Effective date
2011-03-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:27:31

Label at a glance#

ProductBenzocaine
Active ingredientBENZOCAINE
Label structure11 sections

Indications and uses

For temporary relief of pain and itching associated with minor burns, scrapes and insect bites.

Storage and handling

Avoid excessive heat. Store at room temperature: 15 - 30 degrees C (59 - 86 degrees F)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient                             Purpose                  

Benzocaine, 6% w/v                       Topical Analgesic

Isopropyl Alcohol, 70% w/v              Antiseptic

Purpose

OTC - PURPOSE SECTION

  • For temporary relief of pain and itching associated with minor burns, scrapes and insect bites.

Keep Out of Reach of Children

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.

Indications and Usage

INDICATIONS & USAGE SECTION

  • For temporary relief of pain and itching associated with minor burns, scrapes and insect bites.

Warnings

WARNINGS SECTION

Warnings:

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

Dosage

DOSAGE & ADMINISTRATION SECTION

Directions:

  • Adults and children 2 years of age and older, apply to affected area 3-4 times daily.
  • Children under 2 years; consult a physician.




Inactive Ingredients

INACTIVE INGREDIENT SECTION

  • Inactive Ingredient: Water.

Do Not Use

OTC - DO NOT USE SECTION

Do not use: 

  • With electrocautery procedures.
  • In the eyes.

Stop Use

OTC - STOP USE SECTION

Stop use:

  • If irritation and redness develop.
  • If condition persists for more than 72 hours, consult a physician.

Storage and Handling

STORAGE AND HANDLING SECTION

  • Avoid excessive heat.
  • Store at room temperature: 15 - 30 degrees C (59 - 86 degrees F)

Principal Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sting and Bite Pad

BenzocaineBenzocaine

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
67777-235-012019-10-29C16284748780-1960f7f55-c728-8e05-e053-dbdaa90a074aBenzocaine Sting & Bite Pad

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-235-01Benzocaine1 in 1 PACKETSWAB13
67777-235-01Benzocaine3000 in 1 CASESWAB30003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-235BENZOCAINE SWAB [DYNAREX CORPORATION]3Legacy NDC, 2 package rows20110323_bb512b89-0e05-4361-af87-bc27f2e2e7a1.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW53
BENZOCAINEACTIVE MOIETYU3RSY48JW53
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M4163023
WATERINACTIVE INGREDIENT059QF0KO0R3

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67777-23567777-235-01

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
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 ALCOHOLND2M416302TABLET, EXTENDED RELEASE / ORALNAExact 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 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 ALCOHOLND2M416302LOTION, AUGMENTED / TOPICAL2070 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 ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / AURICULAR (OTIC)6 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
30ff050f-234c-41e0-8552-c780c02b7574bb512b89-0e05-4361-af87-bc27f2e2e7a12011-03-22WarningsExact identifier
spl id: 30ff050f-234c-41e0-8552-c780c02b7574
spl set id: bb512b89-0e05-4361-af87-bc27f2e2e7a1

Reported adverse events (FAERS/openFDA)#

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