FDA.reportPublic FDA data

Biofreeze Gel

Manufacturer
Performance Health, LLC
Effective date
2018-11-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:57:11

Label at a glance#

ProductBiofreeze
Active ingredientMENTHOL
Label structure7 sections

Indications and uses

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

Dosage and administration

Adults and children 2 years of age and older: Rub a thin film over affected areas not more than 4 times daily; massage not necessary. Children under 2 years of age: Consult physician

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 4%

Purpose

OTC - PURPOSE SECTION

Cooling Pain Relief

Uses

INDICATIONS & USAGE SECTION

Temporary relief from minor aches and pains of sore muscles & 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 damaged skin
  • Do not use with other ointments, creams, sprays or liniments
  • Do not apply to irritated skin or if excessive irritated develops
  • Do not bandage
  • Wash hands after use with cool water
  • Do not use with heating pad or device
  • Store in a cool dry place

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 recur

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 accidentally ingested, get medical help or contact a Poison Control Center immediately

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older: Rub a thin film over affected areas not more than 4 times daily; massage not necessary.
Children under 2 years of age: Consult physician

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Questions or Comments

OTC - QUESTIONS SECTION

1-800-246-3733

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1111683BIOFREEZE 4 % Topical GelPSN1
415974menthol 4 % Topical GelPSN1
1111683menthol 0.04 MG/MG Topical Gel [Biofreeze]SBD1
415974menthol 0.04 MG/MG Topical GelSCD1
1111683Biofreeze 0.04 MG/MG Topical GelSY1
1111683Biofreeze 4 % Topical GelSY1
415974menthol 4 % Topical GelSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59316-102-80Biofreeze44 mL in 1 TUBEGEL441

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59316-102BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1Current NDC, Legacy NDC, 1 package rows20181108_f0c4d165-a242-4fb5-b2de-d64a825a29e9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59316-102-12ML - Milliliter59316-1028c11b8a5-4f02-41bf-88b6-e4af8c4214f812018-09-05
59316-102-20ML - Milliliter59316-10263342204-7fd4-4732-9ec3-4df580a6e6ce12015-06-09
59316-102-28ML - Milliliter59316-102e8471990-bf89-42b8-8a43-721055ce764512018-09-05
59316-102-30ML - Milliliter59316-1028537e275-8662-4f2c-ae52-44981681af9912024-08-12
59316-102-40ML - Milliliter59316-102030b1aca-eae8-43da-9839-6522c8c985ac12024-08-12
59316-102-50ML - Milliliter59316-10235b2fa59-5fb2-4779-a89d-b84cda16782512024-08-12
59316-102-80ML - Milliliter59316-10239ef3edc-90e7-4701-bbcc-add710ddea6d12024-08-12

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
59316-10259316-102-80

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
FD&C BLUE NO. 1H3R47K3TBDIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
GLYCERINPDC6A3C0OXIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
ISOPROPYL ALCOHOLND2M416302IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
MELISSA OFFICINALIS LEAF50D2ZE9219IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
MENTHOLL7T10EIP3AACTIB

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
BIOFREEZEMENTHOLReckitt Benckiser LLC83d5c2f2-2413-4d28-83b2-0808d0917b4d2026-05-13WarningsExact identifier
ndc (package): 59316-102-80
ndc (product): 59316-102
ndc11 (package): 59316010280
7a195a58-7829-1734-e053-2991aa0a2d96f0c4d165-a242-4fb5-b2de-d64a825a29e92018-11-07WarningsExact identifier
spl id: 7a195a58-7829-1734-e053-2991aa0a2d96
spl set id: f0c4d165-a242-4fb5-b2de-d64a825a29e9

Reported adverse events (FAERS/openFDA)#

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