FDA.reportPublic FDA data

BENGAY ® Menthol Pain Relieving Gel

Manufacturer
Johnson & Johnson Consumer Inc.
Effective date
2018-12-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:43:25

Label at a glance#

ProductBENGAY Pain Relief and Massage
Active ingredientMenthol, unspecified form
Label structure10 sections

Indications and uses

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

Dosage and administration

adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily remove protective cap to open: twist applicator counter-clockwise until it stops squeeze tube to dispense gel to close: twist applicator clockwise until it stops after closing, use applicator to massage in gel after use, clean applicator with damp cloth or paper towel – do not rinse under or immerse in water repl...

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 2.5%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

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

  • simple backache
  • bruises
  • arthritis
  • sprains
  • strains

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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years of age and older:
    • apply to affected area not more than 3 to 4 times daily
    • remove protective cap
    • to open: twist applicator counter-clockwise until it stops
    • squeeze tube to dispense gel
    • to close: twist applicator clockwise until it stops
    • after closing, use applicator to massage in gel
    • after use, clean applicator with damp cloth or paper towel – do not rinse under or immerse in water
    • replace protective cap
  • 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

camphor, carbomer, DMDM hydantoin, isoceteth-20, isopropyl alcohol, PEG-40 hydrogenated castor oil, sodium hydroxide, water

Questions?

OTC - QUESTIONS SECTION

call 1-800-223-0182

PRINCIPAL DISPLAY PANEL - 85 g carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW

BENGAY®
MENTHOL PAIN RELIEVING GEL

pain relief
+ massage

no mess
applicator

massage

vanishing scent

NET WT 3 OZ (85 g)

Principal Display Panel - 85 g carton
Principal Display Panel - 85 g carton

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MentholACTIVE INGREDIENTL7T10EIP3A1
MentholACTIVE MOIETYL7T10EIP3A1

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58232-401558232-4015-1

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
Menthol, unspecified formL7T10EIP3AACTIB
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
DMDM HYDANTOINBYR0546TOWIACT
ISOCETETH-20O020065R7ZIACT
ISOPROPYL ALCOHOLND2M416302IACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT

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
40f2f128-cf45-41e1-b0ce-8a8a0477cbea0cef7083-9fe4-47d7-9229-d1aac749e4b42020-05-21WarningsExact identifier
spl set id: 0cef7083-9fe4-47d7-9229-d1aac749e4b4

Reported adverse events (FAERS/openFDA)#

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