FDA.reportPublic FDA data

Biofreeze Spray

Manufacturer
Reckitt Benckiser LLC
Effective date
2026-07-10
Label type
HUMAN OTC DRUG LABEL
Version
15
Source
daily-update
Hydrated at
2026-07-17 21:45:28

Label at a glance#

ProductBiofreeze Professional
Active ingredientMENTHOL
Label structure8 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: Spray on to the affected areas not more than 4 times daily; massage not necessary Children under 12 years of age: Consult physician Wash hands after use with cool water

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Menthol 13%

Purpose:

OTC - PURPOSE SECTION

Pain Relieving Spray

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.

Flammable:

SPL UNCLASSIFIED SECTION

Keep away from excessive heat or open flame.

SPL UNCLASSIFIED SECTION

Contents Under Pressure. Do Not Punture Or Incinerate Do Not Store At Temperature Above 120°F

Ask a Doctor Before using If You have:

OTC - ASK DOCTOR 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

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

Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur

If pregnant or breast-feeding:

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use

Keep out of reach of children:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If accidentally ingested, get medical help or contact a Poison Control Center immediately

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older:Spray on to the affected areas not more than 4 times daily; massage not necessary
Children under 12 years of age:Consult physician

Wash hands after use with cool water

OTHER SAFETY INFORMATION

􀂄 store at 20-25°C (68-77°F)

􀂄 store in a cool dry place away from direct sunlight

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Alcohol, Arnica Montana Flower Extract, Calendula Officinalis Flower Extract, Camellia Sinensis
Leaf Oil, Chamomilla Recutita (Matricaria) Flower Extract, Echinacea Angustifolia Extract, Glycerin,
Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Juniperus Communis Fruit
Extract, Methylsulfonylmethane, Propylene Glycol, PurifiedWater, Tert-Butyl Alcohol

Questions or Comments:

OTC - QUESTIONS SECTION

1-866-682-4639

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

full carton labelfull carton label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130359316120200GTIN-13: 0359316120200
EAN-13: 0359316120200
GTIN-12: 359316120200
UPC-A: 359316120200
GTIN storage (14 digits): 00359316120200		59316-835 label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59316-83559316-835-20, 59316-835-22

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
ISOPROPYL ALCOHOLND2M416302IACT
TERT-BUTYL ALCOHOLMD83SFE959IACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CHAMOMILEFGL3685T2XIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
ALCOHOL3K9958V90MIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
JUNIPER BERRYO84B5194RLIACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB
ECHINACEA ANGUSTIFOLIA WHOLEVB06AV5US8IACT
TEA LEAF OILVC855RRT77IACT
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
142026-06-02daily-update2026-06-04 05:10:12
132026-05-19full-release2026-06-01 01:58:05
122026-01-14monthly-update2026-06-03 17:53:02

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 ProfessionalMENTHOLReckitt Benckiser LLC485c8208-c93b-5b84-e063-6394a90ab77a2026-07-10WarningsExact identifier
ndc (package): 59316-835-20
ndc (package): 59316-835-22
ndc (product): 59316-835
ndc11 (package): 59316083520
ndc11 (package): 59316083522
spl id: 56453b7f-c5e1-141f-e063-6394a90a629e
spl set id: 485c8208-c93b-5b84-e063-6394a90ab77a

Reported adverse events (FAERS/openFDA)#

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