FDA.reportPublic FDA data

Biofreeze

Manufacturer
Reckitt Benckiser LLC
Effective date
2026-05-13
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:57:42

Label at a glance#

ProductBiofreeze Flexible Relief Strip
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

adults and children 12 years of age and older: Clean and dry affected area, pop apart and partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing the patch to skin and leave in place for up to 8 hours. Use on affected area not more than 3 to 4 times daily. do not stretch the patch during application as it should be comfortable and not tight do not...

Storage and handling

store at 20-25°C (68-77°F) store in a cool dry place away from direct sunlight

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 5.6%

Purpose

OTC - PURPOSE SECTION

Pain Relieving Patch

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.

When using this product

OTC - WHEN USING SECTION

  • use only as directed
  • avoid contact with the eyes or on mucous membranes
  • do not apply to wounds or damaged skin
  • do not apply to irritated skin or if excessive irritation develops
  • do not bandage tightly or use with heating pad or device

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you experience pain, swelling or blistering of the skin
  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • arthritic pain persists for more than 10 days, or redness is present

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,ask a health professional before use.

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

  • adults and children 12 years of age and older: Clean and dry affected area, pop apart and partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing the patch to skin and leave in place for up to 8 hours. Use on affected area not more than 3 to 4 times daily.
  • do not stretch the patch during application as it should be comfortable and not tight
  • do not overwrap or wrap patches over themselves
  • for best adhesion: area should be clean, dry, and smooth
  • children under 12 years of age: consult a physician
  • wash hands after use with cool water

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F)
  • store in a cool dry place away from direct sunlight

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Benzalkonium Chloride, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Isopropyl Myristate, Kaolin, L-Tartaric Acid, Lauralkonium Chloride, Mineral Oil, Nonoxynol-10, Petrolatum, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, PVP, Sodium Polyacrylate, Titanium Dioxide, Water

Questions or comments?

OTC - QUESTIONS SECTION

1-800-246-3733

SPL UNCLASSIFIED SECTION

Dist. by: RB Health (US)
Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 4 Strip Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CLINICALLY
RECOMMENDED*

NDC 59316-004-04

BiOFREEZE ®
COOL THE PAIN

FLEXIBLE
RELIEF
STRIPS
MENTHOL-PAIN
RELIEVING PATCH

Designed to provide up to
8 hours of long lasting
pain relief

Strong adhesion to stay
through any movement

Optimal thickness for
comfort and flexiblity

4 STRIPS |
EXTRA
LONG

10 in x 2 in
(25.4 cm x 5 cm) each

PRINCIPAL DISPLAY PANEL - 4 Strip Carton
PRINCIPAL DISPLAY PANEL - 4 Strip Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2566836menthol 5.6 % Medicated PatchPSN5
2566836menthol 0.056 MG/MG Medicated PatchSCD5
2566836menthol 5.6 % Medicated PatchSY5

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
59316-004-01Biofreeze Flexible Relief Strip6 g in 1 PATCHPATCH65
59316-004-01Biofreeze Flexible Relief Strip1 in 1 POUCHPATCH15
59316-004-04Biofreeze Flexible Relief Strip4 in 1 CARTONPATCH45
59316-004-04Biofreeze Flexible Relief Strip6 g in 1 PATCHPATCH65

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59316-00459316-004-01, 59316-004-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
ALOE VERA LEAFZY81Z83H0XIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
FRANKINCENSER9XLF1R1WMIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
DIHYDROXYALUMINUM AMINOACETATEDO250MG0W6IACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
KAOLIN24H4NWX5COIACT
TARTARIC ACIDW4888I119HIACT
LAURALKONIUM CHLORIDE07HUP5A29XIACT
MINERAL OILT5L8T28FGPIACT
NONOXYNOL-10K7O76887APIACT
PETROLATUM4T6H12BN9UIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
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
Biofreeze Flexible Relief StripMENTHOLReckitt Benckiser LLC6ec26bae-e395-49aa-969e-8c653d6f0b272026-05-13WarningsExact identifier
ndc (package): 59316-004-04
ndc (package): 59316-004-01
ndc (product): 59316-004
ndc11 (package): 59316000404
ndc11 (package): 59316000401
spl id: 51b597cc-806d-e160-e063-6394a90ac1be
spl set id: 6ec26bae-e395-49aa-969e-8c653d6f0b27

Reported adverse events (FAERS/openFDA)#

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