Biofreeze Day & Overnight Patches

Manufacturer
Reckitt Benckiser LLC
Effective date
2026-05-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-06-04 05:10:17

Label at a glance#

ProductBiofreeze Day and Overnight
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure10 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#

OTC - ACTIVE INGREDIENT SECTION

Menthol 5%

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 SECTION

For external use only.

When using this product
■ 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
■ 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

If pregnant or breast-feeding:

ask a health professional before use.

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 INGREDIENT SECTION

Large Patch:

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

Overnight Relief Patch:

Benzalkonium Chloride, Carboxymethylcellulose Sodium, Dihydroxyaluminum
Aminoacetate, Edetate Disodium, Glycerin, Kaolin, Lauralkonium Chloride,
Lavender Oil, Mineral Oil, Petrolatum, Polyacrylic Acid, Polysorbate 80,
Povidone, Propylene Glycol, Purified Water, Sodium Polyacrylate,
Tartaric Acid, Titanium Dioxide

Questions

OTC - QUESTIONS SECTION

1-866-682-4639

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.

OTC - PURPOSE SECTION

Menthol 5%

Purpose:

Pain Relieving Patch

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelLabelLabel

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59316-832-94EA - Each59316-83221677bce-bda1-418b-8359-81883b45724612024-08-12
59316-005-03EA - Each59316-0057e7f9f50-b410-4c12-aa38-8d2f35766da812024-03-12
59316-005-04EA - Each59316-005386d98f5-94c6-4567-a126-8146bffdd32512024-03-12
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 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59316-83259316-832-94
59316-00559316-005-03
59316-99259316-992-07

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 42 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32024-04-04full-release2026-06-01 00:49:25

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Biofreeze Overnight ReliefMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC07be6e88-1850-4d6a-946d-f03830b8c4a22026-05-15WarningsExact identifier
ndc (package): 59316-005-03
ndc (product): 59316-005
ndc11 (package): 59316000503
Biofreeze Day and OvernightMENTHOLReckitt Benckiser LLCfb5c8f89-a720-ad32-e053-6294a90a2abe2026-05-13WarningsExact identifier
ndc (package): 59316-005-03
ndc (package): 59316-832-94
ndc (package): 59316-992-07
ndc (product): 59316-832
ndc11 (package): 59316000503
ndc11 (package): 59316099207
ndc11 (package): 59316083294
spl id: 51b59cc1-4a52-f6d3-e063-6394a90aea69
spl set id: fb5c8f89-a720-ad32-e053-6294a90a2abe
Biofreeze MentholMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC71a36691-9d9e-479d-bfdc-6f6b192ad2d02025-04-11WarningsExact identifier
ndc (package): 59316-992-07
ndc (product): 59316-992
ndc11 (package): 59316099207

Reported adverse events (FAERS/openFDA)#

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