FDA.reportPublic FDA data

BENGAY ® ULTRA STRENGTH PAIN RELIEVING PATCH Large Size

Manufacturer
Kenvue Brands LLC
Effective date
2024-11-06
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:35:15

Label at a glance#

ProductBengay Ultra Strength Large Size
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure11 sections

Indications and uses

temporarily relieves minor aches and pains of muscles and joints associated with: simple backache arthritis strains bruises sprains

Dosage and administration

open pouch and remove patch if desired, cut patch to size peel off protective backing and apply sticky side to affected area 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

Menthol 5%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves 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 the 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

  • open pouch and remove patch
  • if desired, cut patch to size
  • peel off protective backing and apply sticky side to affected area
  • 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

calcined kaolin, cellulose gum, glycerin, methyl acrylate/2-ethylhexyl acrylate copolymer, methylparaben, polyacrylic acid, polysorbate 80, propylparaben, silica, sodium polyacrylate, sodium polyacrylate starch, sorbitan oleate, sorbitol, tartaric acid, titanium dioxide, water

Questions?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 4 Patch Pouch Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ULTRA STRENGTH
MENTHOL 5% TOPICAL ANALGESIC PATCH
BENGAY ®

PAIN RELIEVING PATCH
Targeted relief
that's designed to
stay in place

4 INDIVIDUALLY SEALED PATCH
3.9 IN x 7.9 IN (10 cm x 20 cm)

4
LARGE
FOR BACK TO HIP

PRINCIPAL DISPLAY PANEL - 4 Patch Pouch Carton
PRINCIPAL DISPLAY PANEL - 4 Patch Pouch Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
420222menthol 5 % Medicated PatchPSN7
420222menthol 0.05 MG/MG Medicated PatchSCD7
420222menthol 5 % Medicated PatchSY7

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0487-1Bengay Ultra StrengthLarge Size1 in 1 POUCHPATCH17
69968-0487-1Bengay Ultra StrengthLarge Size1 in 1 CARTONPATCH17
69968-0487-4Bengay Ultra StrengthLarge Size1 in 1 POUCHPATCH17
69968-0487-4Bengay Ultra StrengthLarge Size4 in 1 CARTONPATCH47

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0487BENGAY ULTRA STRENGTH LARGE SIZE (MENTHOL, UNSPECIFIED FORM) PATCH [KENVUE BRANDS LLC]7Current NDC, Legacy NDC, 4 package rows20241108_f57ccc33-400b-4401-a348-c54d1eb9f5d0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69968-0487-1EA - Each69968-04875545ac43-f84c-4dc2-92e6-cddb6afee10312019-08-06

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-048769968-0487-1, 69968-0487-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
KAOLIN24H4NWX5COIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
POLYACRYLIC ACID (8000 MW)73861X4K5FIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLPARABENZ8IX2SC1OHIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
SORBITOL506T60A25RIACT
TARTARIC ACIDW4888I119HIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
WATER059QF0KO0RIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB

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 Large SizeMENTHOL, UNSPECIFIED FORMKenvue Brands LLCf57ccc33-400b-4401-a348-c54d1eb9f5d02024-11-06WarningsExact identifier
ndc (package): 69968-0487-1
ndc (package): 69968-0487-4
ndc (product): 69968-0487
ndc11 (package): 69968048701
ndc11 (package): 69968048704
spl id: 21ff7385-a28f-c8fc-e063-6394a90abdfe
spl set id: f57ccc33-400b-4401-a348-c54d1eb9f5d0

Reported adverse events (FAERS/openFDA)#

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