FDA.reportPublic FDA data

Biofreeze Professional Colorless Gel

Manufacturer
Reckitt Benckiser
Effective date
2026-05-12
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
full-release
Hydrated at
2026-06-01 01:56:51

Label at a glance#

ProductBiofreeze Professional Colorless
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure8 sections

Indications and uses

Temporarily relieves from 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 areas not more than 3 to 4 times daily; •Children under 2 years of age: Consult a physician • wash hands after use with cool water

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#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Menthol USP 5%

Purpose

OTC - PURPOSE SECTION

Pain Relieving Gel

Uses:

INDICATIONS & USAGE SECTION

Temporarily relieves from 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:

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

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:

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 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 areas 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

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

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

Questions or Comments:

OTC - QUESTIONS SECTION

1-800-246-3733

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

full carton labelfull carton label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1794892BIOFREEZE 5 % Topical GelPSN13
415975menthol 5 % Topical GelPSN13
1794892menthol 0.05 MG/MG Topical Gel [Biofreeze]SBD13
415975menthol 0.05 MG/MG Topical GelSCD13
1794892Biofreeze 5 % Topical GelSY13
415975menthol 5 % Topical GelSY13

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130731124445353GTIN-13: 0731124445353
EAN-13: 0731124445353
GTIN-12: 731124445353
UPC-A: 731124445353
GTIN storage (14 digits): 00731124445353		59316-116 label.jpg

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
59316-116-10Biofreeze Professional Colorless89 mL in 1 BOTTLEGEL8913
59316-116-11Biofreeze Professional Colorless3 mL in 1 PACKETGEL313
59316-116-20Biofreeze Professional Colorless118 mL in 1 TUBEGEL11813
59316-116-40Biofreeze Professional Colorless946 mL in 1 BOTTLEGEL94613

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59316-116-20ML - Milliliter59316-1169f98ba32-1370-4a3c-9d30-553c5dce5d7912024-03-12
59316-116-40ML - Milliliter59316-1160d9c7bdf-1499-4bc4-bf40-881d5058400712024-03-12

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
59316-11659316-116-11, 59316-116-20, 59316-116-40, 59316-116-10

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
ARCTIUM LAPPA ROOT597E9BI3Z3IACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
FRANKINCENSER9XLF1R1WMIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
GLYCERINPDC6A3C0OXIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
ISOPROPYL ALCOHOLND2M416302IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
MELISSA OFFICINALIS LEAF50D2ZE9219IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB

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 Professional ColorlessMENTHOL, UNSPECIFIED FORMReckitt Benckiser4639201c-a67a-475f-8df6-3dc6225803ad2026-05-12WarningsExact identifier
ndc (package): 59316-116-10
ndc (package): 59316-116-40
ndc (package): 59316-116-11
ndc (package): 59316-116-20
ndc (product): 59316-116
ndc11 (package): 59316011610
ndc11 (package): 59316011620
ndc11 (package): 59316011611
ndc11 (package): 59316011640
spl id: 51991b66-c6a4-c6d4-e063-6394a90a6f71
spl set id: 4639201c-a67a-475f-8df6-3dc6225803ad

Reported adverse events (FAERS/openFDA)#

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