FDA.reportPublic FDA data

20% Benzocaine Gel

Manufacturer
Bellus Medical, LLC
Effective date
2026-01-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
monthly-update
Hydrated at
2026-06-03 17:51:53

Label at a glance#

ProductBenzocaine
Active ingredientBENZOCAINE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

INACTIVE INGREDIENT SECTION

EthylAlcohol, PEG-8, Purified Water, Carbomer, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid

DOSAGE & ADMINISTRATION SECTION

USES: For the temporary relief of discomfort and pain associated with

  • minor burns and skin irritations
  • minor cuts and scrapes
  • itching

DIRECTIONS: Adults and children 12 years of age and older: Apply to affected area not more than 3-4 times daily.

WARNINGS SECTION

For external use only. Avoid contact with the eyes.

Stop use and ask a doctor if:

  • Skin becomes irritated
  • Condition worsens or symptoms last more than 7 days
  • Symptoms clear up and reoccur within a few days

DO NOT USE: in large quantities, particularly over raw surfaces or blistered areas.

OTC - PURPOSE SECTION

Topical Anesthetic

INDICATIONS & USAGE SECTION

USES: For the temporary relief of discomfort and pain associated with

  • minor burns and skin irritations
  • minor cuts and scrapes
  • itching

DIRECTIONS: Adults and children 12 years of age and older: Apply to affected area not more than 3-4 times daily.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BLT_4ml_Packet_B_170613BLT_4ml_Packet_B_170613

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
452688benzocaine 20 % Topical GelPSN4
452688benzocaine 0.2 MG/MG Topical GelSCD4
452688benzocaine 20 % Topical GelSY4

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
71888-101-022023-10-27C16284748780-19d75b9d1-1e96-f424-e053-dadaa90a57ce20% Benzocaine Gel
71888-101-022023-10-27C16284748780-19d75b9d1-1e96-f424-e053-dadaa90a57ce20% Benzocaine Gel
71888-101-022020-01-31C16284748780-19d75b9d1-1e96-f424-e053-dadaa90a57ce20% Benzocaine Gel
71888-101-022020-01-31C16284748780-19d75b9d1-1e96-f424-e053-dadaa90a57ce20% Benzocaine Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71888-101-01Benzocaine4 mL in 1 PACKETGEL44
71888-101-02Benzocaine12 in 1 BOXGEL124

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
71888-10171888-101-01, 71888-101-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOCAINEU3RSY48JW5ACTIB
POLYETHYLENE GLYCOL 400B697894SGQIACT
SORBIC ACIDX045WJ989BIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32024-11-18full-release2026-06-01 00:37:49

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
BenzocaineBENZOCAINEBellus Medical, LLC60cafbaf-8ec6-46a5-e053-2a91aa0af11f2026-01-09WarningsExact identifier
ndc (package): 71888-101-01
ndc (package): 71888-101-02
ndc (product): 71888-101
ndc11 (package): 71888010101
ndc11 (package): 71888010102
spl id: 47fac2e8-50dd-cddf-e063-6394a90a9176
spl set id: 60cafbaf-8ec6-46a5-e053-2a91aa0af11f

Reported adverse events (FAERS/openFDA)#

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