FDA.reportPublic FDA data

Biofreeze

Manufacturer
Reckitt Benckiser LLC
Effective date
2026-05-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:57:39

Label at a glance#

ProductBiofreeze Menthol
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. children under 12 years of age: consult a physician wash hands after use with cool water

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%

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.
  • 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

1,2-Hexanediol, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Ethylhexylglycerin, Glycerin, Iodopropynyl Butylcarbamate, Kaolin, Mineral Oil, Petrolatum, Phenoxyethanol, Polyacrylic Acid, Polysorbate 80, Povidone, Propylene Glycol, Purified Water, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide

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 - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CLINICALLY
RECOMMENDED*

NDC 59316-887-04

BiOFREEZE ®
COOL THE PAIN

EXTRA LARGE
PATCHES

MENTHOL-PAIN
RELIEVING PATCH

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

Proven cold therapy formula for sore
muscles, simple backaches, and joint pain

Flexible fabric for superior performance and comfort

4 PATCHES | 2 SIZES
EXTRA LARGE
AND LONG

2 EXTRA LARGE 9.84 in x 5.5 in (25 cm x 14 cm) each
2 LONG 7.87 in x 3.94 in (20 cm x 10 cm) each

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2109627Biofreeze 5 % Medicated PatchPSN4
420222menthol 5 % Medicated PatchPSN4
2109627menthol 0.05 MG/MG Medicated Patch [Biofreeze]SBD4
420222menthol 0.05 MG/MG Medicated PatchSCD4
2109627Biofreeze 0.05 MG/MG Medicated PatchSY4
420222menthol 5 % Medicated PatchSY4

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
59316-887-04BiofreezeMenthol1 in 1 KITKIT14
59316-992-32BiofreezeMenthol20 g in 1 PATCHPATCH20 g0.05 g in 1g4
59316-992-32BiofreezeMenthol1 in 1 POUCHPATCH0.05 g in 1g4
59316-992-33BiofreezeMenthol13 g in 1 PATCHPATCH13 g0.05 g in 1g4
59316-992-33BiofreezeMenthol1 in 1 POUCHPATCH0.05 g in 1g4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59316-887-04EA - Each59316-887f1b5bf5e-a838-449a-937a-1aad215af3ad12024-03-12
59316-992-04EA - Each59316-992ce7d8c35-f760-431f-bc8f-185c9b324e2312024-08-12
59316-992-07EA - Each59316-99214757160-2bb7-4dc5-8922-b12629132b8c12022-09-12
59316-992-08EA - Each59316-992fd966c0e-60e6-4700-9ed7-3f0d6e769a6012024-03-12
59316-992-09EA - Each59316-992206abcfe-a47c-4430-aa13-cc3b44a8beef12024-03-12
59316-992-33EA - Each59316-992d0afdc86-c697-4b41-a846-8abf328782bf12024-03-12

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
59316-88759316-887-04
59316-99259316-992-32, 59316-992-33

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 46 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
FRANKINCENSER9XLF1R1WMIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
DIHYDROXYALUMINUM AMINOACETATEDO250MG0W6IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
KAOLIN24H4NWX5COIACT
MINERAL OILT5L8T28FGPIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PETROLATUM4T6H12BN9UIACT
POLYACRYLIC ACID (450000 MW)KD3S7H73D3IACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
TARTARIC ACIDW4888I119HIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
WATER059QF0KO0RIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
1,2-HEXANEDIOLTR046Y3K1GIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
ALOE VERA LEAFZY81Z83H0XIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
FRANKINCENSER9XLF1R1WMIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
DIHYDROXYALUMINUM AMINOACETATEDO250MG0W6IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
KAOLIN24H4NWX5COIACT
MINERAL OILT5L8T28FGPIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PETROLATUM4T6H12BN9UIACT
POLYACRYLIC ACID (450000 MW)KD3S7H73D3IACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Biofreeze MentholMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC3f2b1f48-2d78-4985-a046-9f72de5e1a9b2026-05-13WarningsExact identifier
ndc (package): 59316-887-04
ndc (package): 59316-992-32
ndc (package): 59316-992-33
ndc (product): 59316-887
ndc11 (package): 59316099233
ndc11 (package): 59316099232
ndc11 (package): 59316088704
spl id: 51b56b5f-5a3c-cc70-e063-6294a90a4580
spl set id: 3f2b1f48-2d78-4985-a046-9f72de5e1a9b
Biofreeze MentholMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC71a36691-9d9e-479d-bfdc-6f6b192ad2d02025-04-11WarningsExact identifier
ndc (package): 59316-992-32
ndc (package): 59316-992-33
ndc (product): 59316-992
ndc11 (package): 59316099233
ndc11 (package): 59316099232

Reported adverse events (FAERS/openFDA)#

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