FDA.reportPublic FDA data

BENGAY ® ULTRA STRENGTH NON-GREASY CREAM

Manufacturer
Kenvue Brands LLC
Effective date
2024-12-11
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:42:41

Label at a glance#

ProductBENGAY ULTRA STRENGTH NON-GREASY
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE
Label structure10 sections

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

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientPurpose
Camphor 4%Topical analgesic
Menthol 10%Topical analgesic
Methyl salicylate 30%Topical analgesic

Use

INDICATIONS & USAGE SECTION

temporarily relieves the minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis-like conditions

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have redness over affected area

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

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
  • excessive skin irritation occurs

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

carbomer, disodium EDTA, glyceryl stearate SE, lanolin, polysorbate 80, potassium hydroxide, stearic acid, triethanolamine, water

Questions?

OTC - QUESTIONS SECTION

call 1-800-223-0182 (toll-free) or 215-273-8755 (collect)

SPL UNCLASSIFIED SECTION

Distributed by:
Kenvue Brands LLC
Summit, NJ 07901

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ULTRA STRENGTH

TOPICAL ANALGESIC CREAM

BENGAY ®

With three

ingredients for

powerful relief

at the site of pain

Camphor 4%

Menthol 10%

Methyl

Salicylate 30%

NET WT 4 OZ (113 g)

Bengay_1Bengay_1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
283083camphor 4 % / menthol 10 % / methyl salicylate 30 % Topical CreamPSN9
283083camphor 40 MG/ML / menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical CreamSCD9
283083camphor 4 % / menthol 10 % / methyl salicylate 30 % Topical CreamSY9

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0538-2BENGAY ULTRA STRENGTH NON-GREASY1 in 1 CARTONCREAM19
69968-0538-2BENGAY ULTRA STRENGTH NON-GREASY57 g in 1 TUBECREAM579
69968-0538-4BENGAY ULTRA STRENGTH NON-GREASY113 g in 1 TUBECREAM1139
69968-0538-4BENGAY ULTRA STRENGTH NON-GREASY1 in 1 CARTONCREAM19
69968-0538-5BENGAY ULTRA STRENGTH NON-GREASY2 in 1 CARTONCREAM29
69968-0538-5BENGAY ULTRA STRENGTH NON-GREASY113 g in 1 TUBECREAM1139

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0538BENGAY ULTRA STRENGTH NON-GREASY (CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [KENVUE BRANDS LLC]9Current NDC, Legacy NDC, 6 package rows20241215_0a41ec65-bd0b-4fc6-807d-74f353341cc7.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-053869968-0538-2, 69968-0538-4, 69968-0538-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
LANOLIN7EV65EAW6HIACT
POLYSORBATE 806OZP39ZG8HIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
STEARIC ACID4ELV7Z65APIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB

Source Document#

Source XML · Source PDF

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 ULTRA STRENGTH NON-GREASYCAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATEKenvue Brands LLC0a41ec65-bd0b-4fc6-807d-74f353341cc72024-12-11WarningsExact identifier
ndc (package): 69968-0538-2
ndc (package): 69968-0538-4
ndc (package): 69968-0538-5
ndc (product): 69968-0538
ndc11 (package): 69968053804
ndc11 (package): 69968053802
ndc11 (package): 69968053805
spl id: 28fcca55-7990-dba5-e063-6294a90aac6a
spl set id: 0a41ec65-bd0b-4fc6-807d-74f353341cc7

Reported adverse events (FAERS/openFDA)#

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