FDA.reportPublic FDA data

Biofreeze

Manufacturer
Reckitt Benckiser LLC
Effective date
2026-05-13
Label type
HUMAN OTC DRUG LABEL
Version
31
Source
full-release
Hydrated at
2026-06-01 01:57:43

Label at a glance#

ProductBiofreeze Colorless
Active ingredientMENTHOL, UNSPECIFIED FORM
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

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#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 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.

SPL UNCLASSIFIED SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

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, Camphor, 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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 89 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CLINICALLY
RECOMMENDED*

BiOFREEZE ®
COOL THE PAIN

NDC 59316-103-12

COLORLESS GEL

MENTHOL-PAIN
RELIEVING GEL

3 FL OZ (89 mL)

PRINCIPAL DISPLAY PANEL - 89 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 89 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1111683BIOFREEZE 4 % Topical GelPSN31
415974menthol 4 % Topical GelPSN31
1111683menthol 0.04 MG/MG Topical Gel [Biofreeze]SBD31
415974menthol 0.04 MG/MG Topical GelSCD31
1111683Biofreeze 0.04 MG/MG Topical GelSY31
1111683Biofreeze 4 % Topical GelSY31
415974menthol 4 % Topical GelSY31

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59316-103-10Biofreeze Colorless5 mL in 1 BOTTLEGEL531
59316-103-11Biofreeze Colorless3 mL in 1 BOTTLEGEL331
59316-103-12Biofreeze Colorless89 mL in 1 BOTTLEGEL8931
59316-103-15Biofreeze Colorless89 mL in 1 BOTTLE, WITH APPLICATORGEL8931
59316-103-20Biofreeze Colorless118 mL in 1 BOTTLEGEL11831
59316-103-28Biofreeze Colorless273 mL in 1 BOTTLEGEL27331
59316-103-40Biofreeze Colorless946 mL in 1 BOTTLEGEL94631

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59316-103-12ML - Milliliter59316-103b52397a8-ed9d-4dc6-b82e-39964b2d6c6a12018-05-09
59316-103-20ML - Milliliter59316-103700d69bb-759b-4ca7-941b-78f7b222594012024-06-10
59316-103-40ML - Milliliter59316-1030770d763-3f20-4da3-91bb-9cc65a6fddcf12024-08-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3A15
MENTHOLACTIVE MOIETYL7T10EIP3A15
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X15
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L015
ARCTIUM LAPPA ROOTINACTIVE INGREDIENT597E9BI3Z315
ARNICA MONTANA FLOWERINACTIVE INGREDIENTOZ0E5Y15PZ15
CALENDULA OFFICINALIS FLOWERINACTIVE INGREDIENTP0M7O4Y7YD15
CAMPHOR (SYNTHETIC)INACTIVE INGREDIENT5TJD82A1ET15
FRANKINCENSEINACTIVE INGREDIENTR9XLF1R1WM15
GLYCERININACTIVE INGREDIENTPDC6A3C0OX15
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B015
ILEX PARAGUARIENSIS LEAFINACTIVE INGREDIENT1Q953B4O4F15
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M41630215
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJS15
MELISSA OFFICINALIS LEAFINACTIVE INGREDIENT50D2ZE921915
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU415
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK15
WATERINACTIVE INGREDIENT059QF0KO0R15

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59316-10359316-103-40, 59316-103-10, 59316-103-11, 59316-103-15, 59316-103-20, 59316-103-12, 59316-103-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
ARCTIUM LAPPA ROOT597E9BI3Z3IACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
FRANKINCENSER9XLF1R1WMIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
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

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 80 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
24 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSGEL / TOPICAL29 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / TOPICAL6 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
CAMPHOR (SYNTHETIC)CAMPHOR (SYNTHETIC)5TJD82A1ETDROPS / OPHTHALMICNAExact identifier — unii candidate
16 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / TOPICAL6 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
24 equally ranked IID candidates
CAMPHOR (SYNTHETIC)CAMPHOR (SYNTHETIC)5TJD82A1ETJELLY / NASAL65 mgExact identifier — unii candidate
16 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
CAMPHOR (SYNTHETIC)CAMPHOR (SYNTHETIC)5TJD82A1ETDROPS / OPHTHALMICNAExact identifier — unii candidate
16 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSGEL / TOPICAL29 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSGEL / TOPICAL29 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
24 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
24 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
24 equally ranked IID candidates
CAMPHOR (SYNTHETIC)CAMPHOR (SYNTHETIC)5TJD82A1ETDROPS / OPHTHALMICNAExact identifier — unii candidate
16 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSGEL / TOPICAL29 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSGEL / TOPICAL29 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
24 equally ranked IID candidates
CAMPHOR (SYNTHETIC)CAMPHOR (SYNTHETIC)5TJD82A1ETDROPS / OPHTHALMICNAExact identifier — unii candidate
16 equally ranked IID candidates
CAMPHOR (SYNTHETIC)CAMPHOR (SYNTHETIC)5TJD82A1ETJELLY / NASAL65 mgExact identifier — unii candidate
16 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
24 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
24 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
24 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
CAMPHOR (SYNTHETIC)CAMPHOR (SYNTHETIC)5TJD82A1ETJELLY / NASAL65 mgExact identifier — unii candidate
16 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
24 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
CAMPHOR (SYNTHETIC)CAMPHOR (SYNTHETIC)5TJD82A1ETJELLY / NASAL65 mgExact identifier — unii candidate
16 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
24 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
24 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / TOPICAL6 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
24 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
24 equally ranked IID candidates
CAMPHOR (SYNTHETIC)CAMPHOR (SYNTHETIC)5TJD82A1ETDROPS / OPHTHALMICNAExact identifier — unii candidate
16 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
24 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
24 equally ranked IID candidates
CAMPHOR (SYNTHETIC)CAMPHOR (SYNTHETIC)5TJD82A1ETDROPS / OPHTHALMICNAExact identifier — unii candidate
16 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
24 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSGEL / TOPICAL29 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
24 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSGEL / TOPICAL29 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / TOPICAL6 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
CAMPHOR (SYNTHETIC)CAMPHOR (SYNTHETIC)5TJD82A1ETJELLY / NASAL65 mgExact identifier — unii candidate
16 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / TOPICAL6 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
24 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
24 equally ranked IID candidates
CAMPHOR (SYNTHETIC)CAMPHOR (SYNTHETIC)5TJD82A1ETJELLY / NASAL65 mgExact identifier — unii candidate
16 equally ranked IID candidates

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 ColorlessMENTHOLReckitt Benckiser LLC939dbbc3-71ec-4990-840e-7c9b8d4305622026-05-13WarningsExact identifier
ndc (package): 59316-103-20
ndc (package): 59316-103-15
ndc (package): 59316-103-10
ndc (package): 59316-103-40
ndc (package): 59316-103-12
ndc (package): 59316-103-11
ndc (package): 59316-103-28
ndc (product): 59316-103
ndc11 (package): 59316010328
ndc11 (package): 59316010320
ndc11 (package): 59316010315
ndc11 (package): 59316010310
ndc11 (package): 59316010312
ndc11 (package): 59316010311
ndc11 (package): 59316010340
spl id: 51b597cc-8068-e160-e063-6394a90ac1be
spl set id: 939dbbc3-71ec-4990-840e-7c9b8d430562

Reported adverse events (FAERS/openFDA)#

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