FDA.reportPublic FDA data

BENGAY

Manufacturer
Kenvue Brands LLC
Effective date
2024-11-06
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:35:03

Label at a glance#

ProductBENGAY Tropical Jasmine
Active ingredientLIDOCAINE
Label structure11 sections

Indications and uses

For the temporary relief of pain

Dosage and administration

use only as directed adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily children under 12 years of age: ask a doctor

Storage and handling

store at 20° to 25°C (68° to 77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 4%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • in large quantities, particularly over raw surfaces or blistered areas

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • use only as directed
  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

store at 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

acrylates/C10-30 alkyl acrylate crosspolymer, aminomethyl propanol, butylene glycol, caprylyl glycol, ceteth-10 phosphate, cetostearyl alcohol, dicetyl phosphate, dimethicone, fragrance, glycerin, glyceryl distearate, glyceryl monostearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, phenoxyethanol, polysorbate 60, SD alcohol 40-B, squalane, steareth-21, water

Questions?

OTC - QUESTIONS SECTION

call 1-800-223-0182 (toll-free) or 215-273-8755 (collect) or visit www.bengay.com

SPL UNCLASSIFIED SECTION

Distributed by:
JOHNSON & JOHNSON CONSUMER INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LIDOCAINE 4%
TOPICAL ANALGESIC CREAM
BENGAY ®
Maximum
Strength
Lidocaine

Tropical
Jasmine
Scent

NET WT 3.0 OZ (85 g)

Principal Display Panel - 85 g Tube Carton
Principal Display Panel - 85 g Tube Carton

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0614-3BENGAYTropical Jasmine1 in 1 CARTONCREAM16
69968-0614-3BENGAYTropical Jasmine85 g in 1 TUBECREAM856

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0614BENGAY TROPICAL JASMINE (LIDOCAINE) CREAM [KENVUE BRANDS LLC]6Current NDC, Legacy NDC, 2 package rows20241108_c416320a-c0d7-401e-b0fa-44114d76a557.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69968-0614-3GM - Gram69968-0614302c4bcd-9e1a-4e2d-a290-18d95bab87db12020-05-08

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-061469968-0614-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CETETH-10 PHOSPHATE4E05O5N49GIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DIHEXADECYL PHOSPHATE2V6E5WN99NIACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL DISTEARATE73071MW2KMIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 60CAL22UVI4MIACT
ALCOHOL3K9958V90MIACT
SQUALANEGW89575KF9IACT
STEARETH-2153J3F32P58IACT
WATER059QF0KO0RIACT
LIDOCAINE98PI200987ACTIB

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
BENGAY Tropical JasmineLIDOCAINEKenvue Brands LLCc416320a-c0d7-401e-b0fa-44114d76a5572024-11-06WarningsExact identifier
ndc (package): 69968-0614-3
ndc (product): 69968-0614
ndc11 (package): 69968061403
spl id: 21bef90f-b302-4924-e063-6294a90a6ea2
spl set id: c416320a-c0d7-401e-b0fa-44114d76a557

Reported adverse events (FAERS/openFDA)#

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