BioFreeze Day & Overnight Roll-On

Manufacturer
Reckitt Benckiser LLC
Effective date
2026-05-15
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:57:40

Label at a glance#

ProductBiofreeze Roll-On and Overnight Roll-On
Active ingredientMENTHOL, UNSPECIFIED FORM, MENTHOL
Label structure10 sections

Indications and uses

Uses Roll-on: Temporarily relieves minor aches and pains of muscles and joints associated with: ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains Uses Overnight Roll-on: Temporarily relieves minor aches and pains of muscles and joints associated with: ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains

Dosage and administration

Directions Roll-on: ■ adults and children 2 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily ■ children under 2 years of age: consult a physician ■ wash hands after use with cool water Directions Overnight Roll-on: ■ adults and children 2 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily ■ children under 2 years of age: consult a ...

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

Roll-on/Overnight Roll-on:

Menthol 4%

Uses

INDICATIONS & USAGE SECTION

Uses

Roll-on:

Temporarily relieves minor aches and pains of
muscles and joints associated with: ■ simple backache
■ arthritis ■ strains ■ bruises ■ sprains

Uses

Overnight Roll-on:

Temporarily relieves minor aches and pains of
muscles and joints associated with: ■ simple backache
■ arthritis ■ strains ■ bruises ■ sprains

WARNINGS SECTION

Warnings

Roll-on:


For external use only.
Flammable: Keep away from excessive heat or open flame
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, or in conditions affecting children under 12 years
of age

Warnings

Overnight Roll-on:


For external use only.
Flammable: Keep away from excessive heat or open flame
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
■ children 2 years to under 12 years of age: use only under
adult supervision


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, or in conditions affecting children under 12 years
of age

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

Roll-on:


■ adults and children 2 years of age and older: rub a thin
film over affected area not more than 3 to 4 times daily
■ children under 2 years of age: consult a physician
■ wash hands after use with cool water

Directions

Overnight Roll-on:


■ adults and children 2 years of age and older: rub a thin
film over affected area not more than 3 to 4 times daily
■ children under 2 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

Questions

OTC - QUESTIONS SECTION

Questions or comments? 1-800-246-3733

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

OTC - PURPOSE SECTION

Purpose:

Pain Relieving Gel

INACTIVE INGREDIENT SECTION

Roll-on:

Aloe Barbadensis Leaf Extract, Arctium Lappa Root (Burdock)
Extract, Arnica Montana Flower Extract, Blue 1, Boswellia
Carterii Resin Extract, Calendula Officinalis Extract, Camellia
Sinensis Leaf Extract, Camphor, Carbomer, Glycerin, Ilex
Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl
Myristate, Melissa Officinalis (Lemon Balm) Leaf Extract,
Silica, Tocopheryl Acetate, Triethanolamine,Water, Yellow 5

Overnight Roll-on:

Alcohol, Aloe Barbadensis Leaf Extract, Arctium Lappa Root
Extract, Arnica Montana Flower Extract, Boswellia Carterii
Resin Extract, Calendula Officinalis Leaf Extract, Camellia
Sinensis Leaf Extract, Carbomer Interpolymer, Colloidal Silicon
Dioxide, Fragrance, Glycerin, Ilex Paraguariensis Leaf Extract,
Isopropyl Alcohol, Melissa Officinalis Leaf Extract, Purified
Water, Tocopherol Acetate, Trolamine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

full carton labelfull carton label

back labelback label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1111683BIOFREEZE 4 % Topical GelPSN5
415974menthol 4 % Topical GelPSN5
1111683menthol 0.04 MG/MG Topical Gel [Biofreeze]SBD5
415974menthol 0.04 MG/MG Topical GelSCD5
1111683Biofreeze 0.04 MG/MG Topical GelSY5
1111683Biofreeze 4 % Topical GelSY5
415974menthol 4 % Topical GelSY5

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59316-205-14Biofreeze Roll-On and Overnight Roll-On74 mL in 1 BOTTLEGEL74 mL40 mg in 1mL5
59316-207-14Biofreeze Roll-On and Overnight Roll-On74 mL in 1 BOTTLEGEL74 mL40 mg in 1mL5
59316-209-14Biofreeze Roll-On and Overnight Roll-On1 in 1 BOTTLEKIT15
59316-209-14Biofreeze Roll-On and Overnight Roll-On2 in 1 KITKIT25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59316-205-10ML - Milliliter59316-20514d40e2b-5615-41bd-a594-c7c596c2427b12024-06-10
59316-205-14ML - Milliliter59316-205cd2e340d-0c11-4803-a4f5-ecfbd7e195ce12022-09-12
59316-207-14ML - Milliliter59316-207984f94ed-b81d-4470-a2af-d26d054baea712024-02-14

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59316-20959316-209-14
59316-20559316-205-14
59316-20759316-207-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42026-03-17monthly-update2026-06-03 18:00:26

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 Roll-onMENTHOLReckitt Benckiser LLCf67d7b7a-8922-73f6-e053-2995a90a2e802026-05-15WarningsExact identifier
ndc (package): 59316-207-14
ndc (product): 59316-207
ndc11 (package): 59316020714
Biofreeze Roll-On and Overnight Roll-OnMENTHOLReckitt Benckiser LLC4d3dcb8f-2075-6bbc-e063-6394a90a49922026-05-15WarningsExact identifier
ndc (package): 59316-205-14
ndc (package): 59316-207-14
ndc (package): 59316-209-14
ndc (product): 59316-209
ndc11 (package): 59316020714
ndc11 (package): 59316020914
ndc11 (package): 59316020514
spl id: 51e076b8-984a-b24a-e063-6294a90ae9c0
spl set id: 4d3dcb8f-2075-6bbc-e063-6394a90a4992
Biofreeze Roll-OnMENTHOLReckitt Benckiser LLCebbbe9cb-b1ce-4dac-9fca-f54a2470c4fb2026-05-15WarningsExact identifier
ndc (package): 59316-205-14
ndc (product): 59316-205
ndc11 (package): 59316020514

Reported adverse events (FAERS/openFDA)#

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