FDA.reportPublic FDA data

Biofreeze Overnight Gel

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 01:57:45

Label at a glance#

ProductBiofreeze Overnight Gel
Active ingredientMENTHOL
Label structure11 sections

Indications and uses

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

Dosage and administration

Directions ¢ 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#

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 breastfeeding:

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

Directions

¢ 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 Info

OTHER SAFETY INFORMATION

Other information

¢ store at 20-25°C (68-77°F)

¢ store in a cool dry place away from direct sunlight

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients

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, Fragrance, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Melissa Officinalis Leaf Extract, Purified Water, Tocopherol Acetate, Trolamine

OTC - QUESTIONS SECTION

Questions or comments? 1-800-246-3733

Drug Facts

SPL UNCLASSIFIED SECTION

Dist. by: RB Health (US)
Parsippany, NJ 07054-0224

Uses

INDICATIONS & USAGE SECTION

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with:

¢ simple backache ¢ arthritis ¢ strains ¢ bruises ¢ sprains

Active

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Menthol 4% Purpose-Pain Relieving Gel

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

Temporarily relieves minor aches and pains of muscles and joints associated with:

¢ simple backache ¢ arthritis ¢ strains ¢ bruises ¢ sprains

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 59316-121-10

BiOFREEZE®

GEL

MENTHOL-PAIN
RELIEVING GEL

3 FL OZ 89 mL

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
59316-121-10Biofreeze Overnight Gel89 mL in 1 BOTTLEGEL893

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59316-121-10ML - Milliliter59316-1217f28a9d8-6572-47d0-b64b-d01bd794e6cd12024-02-14

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
59316-12159316-121-10

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
ALOE VERA LEAFZY81Z83H0XIACT
ARCTIUM LAPPA ROOT597E9BI3Z3IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
FRANKINCENSER9XLF1R1WMIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
MENTHOLL7T10EIP3AACTIB
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
ISOPROPYL ALCOHOLND2M416302IACT
MELISSA OFFICINALIS LEAF50D2ZE9219IACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Biofreeze Overnight GelMENTHOLReckitt Benckiser LLCf5c8c08b-c7c0-f84d-e053-2a95a90add152026-05-15WarningsExact identifier
ndc (package): 59316-121-10
ndc (product): 59316-121
ndc11 (package): 59316012110
spl id: 51e06548-d75f-53d6-e063-6294a90a66eb
spl set id: f5c8c08b-c7c0-f84d-e053-2a95a90add15

Reported adverse events (FAERS/openFDA)#

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