FDA.reportPublic FDA data

Biofreeze Pain Relieving Spray

Manufacturer
Reckitt Benckiser LLC | Span Packaging Services LLC dba Multi-Pack Solutions
Effective date
2026-05-13
Label type
HUMAN OTC DRUG LABEL
Version
40
Source
full-release
Hydrated at
2026-06-01 01:57:21

Label at a glance#

ProductBiofreeze
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure9 sections

Indications and uses

Temporary relief from minor aches and pains of sore muscles and joints associated with: -arthritis - backache - strains - 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 a physician

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Menthol USP 10%

Purpose

OTC - PURPOSE SECTION

Cooling Pain Reliever

Uses:

INDICATIONS & USAGE SECTION

Temporary relief from minor aches and pains of sore muscles and joints associated with: -arthritis - backache - strains - sprains

Warnings:

WARNINGS SECTION

For external use only

Flammable: Keep away from excessive heat or open flame

Ask a doctor before use if you have:

OTC - ASK DOCTOR SECTION

sensitive skin

When Using This Product:

OTC - WHEN USING SECTION

-Avoid contact with the eyes or mucous membranes - Do not apply to wounds or damages skin -Do not use with other ointments, creams, sprays or liniments -Do not apply to irritated skin or if excessive irritation develops -Do not bandage - Wash hands after use with cool water -Do not 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 reoccur

If pregnant or breastfeeding:

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 a physician

Other Information:

SPL UNCLASSIFIED SECTION

Store in a cool dry place with lid closed tightly

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Arnica Montana, Calendula,Chamomile, Dimethyl Sulfone, Echinacea, Ethanol,  ilex Paraguarenis, Isopropyl Myristate, Juniper Berry, water, White Tea

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 - 473 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PENETRATING, LONG LASTING PAIN RELIEF FROM:
ARTHRITIS • SORE MUSCLES & JOINTS • BACK PAIN

BIOFREEZE ®
PAIN RELIEVING Spray

WITH SOOTHING MENTHOL

Cryotherapy - The Cold Method ®

16 fl. oz./473mL

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043232BIOFREEZE 10 % Topical SprayPSN40
667889menthol 10 % Topical SprayPSN40
1043232menthol 100 MG/ML Topical Spray [Biofreeze]SBD40
667889menthol 100 MG/ML Topical SpraySCD40
1043232Biofreeze 10 % Topical SpraySY40
1043232Biofreeze 100 MG/ML Topical SpraySY40
667889menthol 10 % Topical SpraySY40

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59316-104-10Biofreeze59 mL in 1 BOTTLE, SPRAYSPRAY5940
59316-104-20Biofreeze118 mL in 1 BOTTLE, SPRAYSPRAY11840
59316-104-25Biofreeze118 mL in 1 BOTTLE, SPRAYSPRAY11840
59316-104-30Biofreeze473 mL in 1 BOTTLE, SPRAYSPRAY47340

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3A24
MENTHOLACTIVE MOIETYL7T10EIP3A24
ALCOHOLINACTIVE INGREDIENT3K9958V90M24
ARNICA MONTANAINACTIVE INGREDIENTO80TY208ZW24
CALENDULA OFFICINALIS FLOWERINACTIVE INGREDIENTP0M7O4Y7YD24
CHAMOMILEINACTIVE INGREDIENTFGL3685T2X24
DIMETHYL SULFOXIDEINACTIVE INGREDIENTYOW8V9698H24
ECHINACEA, UNSPECIFIEDINACTIVE INGREDIENT4N9P6CC1DX24
ILEX PARAGUARIENSIS LEAFINACTIVE INGREDIENT1Q953B4O4F24
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJS24
JUNIPERUS COMMUNIS WHOLEINACTIVE INGREDIENT464910T5N924
WATERINACTIVE INGREDIENT059QF0KO0R24

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59316-10459316-104-10, 59316-104-20, 59316-104-30, 59316-104-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARNICA MONTANA WHOLEO80TY208ZWIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CHAMOMILEFGL3685T2XIACT
DIMETHYL SULFOXIDEYOW8V9698HIACT
ECHINACEA, UNSPECIFIED4N9P6CC1DXIACT
ALCOHOL3K9958V90MIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
JUNIPERUS COMMUNIS WHOLE464910T5N9IACT
WATER059QF0KO0RIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 20 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
DIMETHYL SULFOXIDEDIMETHYL SULFOXIDEYOW8V9698HLOTION / TOPICAL45.5 %w/wExact identifier — unii+route
10 equally ranked IID candidates
DIMETHYL SULFOXIDEDIMETHYL SULFOXIDEYOW8V9698HSOLUTION / TOPICAL8008 mgExact identifier — unii+route
10 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSSPRAY / TOPICAL3665 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
DIMETHYL SULFOXIDEDIMETHYL SULFOXIDEYOW8V9698HLOTION / TOPICAL45.5 %w/wExact identifier — unii+route
10 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSSPRAY / TOPICAL3665 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
DIMETHYL SULFOXIDEDIMETHYL SULFOXIDEYOW8V9698HSOLUTION / TOPICAL8008 mgExact identifier — unii+route
10 equally ranked IID candidates
DIMETHYL SULFOXIDEDIMETHYL SULFOXIDEYOW8V9698HLOTION / TOPICAL45.5 %w/wExact identifier — unii+route
10 equally ranked IID candidates
DIMETHYL SULFOXIDEDIMETHYL SULFOXIDEYOW8V9698HSOLUTION / TOPICAL8008 mgExact identifier — unii+route
10 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSSPRAY / TOPICAL3665 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
DIMETHYL SULFOXIDEDIMETHYL SULFOXIDEYOW8V9698HLOTION / TOPICAL45.5 %w/wExact identifier — unii+route
10 equally ranked IID candidates
DIMETHYL SULFOXIDEDIMETHYL SULFOXIDEYOW8V9698HSOLUTION / TOPICAL8008 mgExact identifier — unii+route
10 equally ranked IID candidates
DIMETHYL SULFOXIDEDIMETHYL SULFOXIDEYOW8V9698HSOLUTION / TOPICAL8008 mgExact identifier — unii+route
10 equally ranked IID candidates
DIMETHYL SULFOXIDEDIMETHYL SULFOXIDEYOW8V9698HLOTION / TOPICAL45.5 %w/wExact identifier — unii+route
10 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSSPRAY / TOPICAL3665 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSSPRAY / TOPICAL3665 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates

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
BiofreezeMENTHOLReckitt Benckiser LLC5edddb99-6596-4a3b-b361-1cc04d032c312026-05-13WarningsExact identifier
ndc (package): 59316-104-25
ndc (package): 59316-104-20
ndc (package): 59316-104-30
ndc (package): 59316-104-10
ndc (product): 59316-104
ndc11 (package): 59316010410
ndc11 (package): 59316010420
ndc11 (package): 59316010430
ndc11 (package): 59316010425
spl id: 51b427be-af9f-1fbe-e063-6394a90acada
spl set id: 5edddb99-6596-4a3b-b361-1cc04d032c31

Reported adverse events (FAERS/openFDA)#

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