BiOFREEZE ® Overnight Roll-on

Manufacturer
Reckitt Benckiser LLC
Effective date
2026-05-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:57:46

Label at a glance#

ProductBiofreeze Overnight Roll-on
Active ingredientMENTHOL
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 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

Label contents#

Full prescribing information#

Active

OTC - ACTIVE INGREDIENT SECTION

Mentol USP 4%

Purpose

OTC - PURPOSE SECTION

Pain Relieving Gel

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: 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

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 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

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, 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

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 - 74 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CLINICALLY RECOMMENDED

NDC 59316-207-14

BIOFREEZE

COOL THE PAIN

ROLL-ON

MENTHOL- PAIN RELIEVING GEL

2.5 FL OZ (74mL)

SHAKE WELL BEFORE EACH USE

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1111683BIOFREEZE 4 % Topical GelPSN3
415974menthol 4 % Topical GelPSN3
1111683menthol 0.04 MG/MG Topical Gel [Biofreeze]SBD3
415974menthol 0.04 MG/MG Topical GelSCD3
1111683Biofreeze 0.04 MG/MG Topical GelSY3
1111683Biofreeze 4 % Topical GelSY3
415974menthol 4 % Topical GelSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59316-207-14Biofreeze Overnight Roll-on74 mL in 1 BOTTLEGEL743

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
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 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59316-20759316-207-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

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 Overnight Roll-onMENTHOLReckitt Benckiser LLCf67d7b7a-8922-73f6-e053-2995a90a2e802026-05-15WarningsExact identifier
ndc (package): 59316-207-14
ndc (product): 59316-207
ndc11 (package): 59316020714
spl id: 51e06d5e-11fe-5814-e063-6294a90a2736
spl set id: f67d7b7a-8922-73f6-e053-2995a90a2e80
Biofreeze Roll-On and Overnight Roll-OnMENTHOLReckitt Benckiser LLC4d3dcb8f-2075-6bbc-e063-6394a90a49922026-05-15WarningsExact identifier
ndc (package): 59316-207-14
ndc11 (package): 59316020714

Reported adverse events (FAERS/openFDA)#

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