FDA.reportPublic FDA data

Biofreeze Cream

Manufacturer
Reckitt Benckiser LLC
Effective date
2026-05-13
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:57:43

Label at a glance#

ProductBiofreeze
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure7 sections

Indications and uses

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

Dosage and administration

• Adults and Children 12 years of age and older: Rub a thin film over affected areas not more four times daily; massage not necessary • Children under 12 years of age: Consult physician

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Menthol USP 10%

Purpose

OTC - PURPOSE SECTION

Cooling Pain Relief

Uses:

INDICATIONS & USAGE SECTION

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

Warnings:

WARNINGS SECTION

For external use only

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 irritation 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 breastfeeding:

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 12 years of age and older:Rub a thin film over affected areas not more four times daily; massage not necessary
• Children under 12 years of age:Consult physician

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Caprylic/Capric Triglyceride, Caprylyl Glycol, Alcohol, Dimethicone, Gluconolactone Glycerin, Glyceryl Stearate, Hydroxyacetophenone, Ilex Paraguariensis Leaf Extract, Iodopropynyl Butylcarbamate, Phenoxyethanol, Polysorbate 60, Sodium Benzoate, Sodium Hydroxide, Sodium Stearoyl Lactylate, Tocopheryl Acetate, Vitis Vinifera (Grape) Seed Oil, Water,Calcium Gluconate, Cetostearyl Alcohol, Edetate Sodium, Isopropyl Alcohol, PEG-4 Laurate

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
2001133BIOFREEZE 10 % Topical CreamPSN7
253020menthol 10 % Topical CreamPSN7
2001133menthol 100 MG/ML Topical Cream [Biofreeze]SBD7
253020menthol 100 MG/ML Topical CreamSCD7
2001133Biofreeze 10 % Topical CreamSY7
2001133Biofreeze 100 MG/ML Topical CreamSY7
253020menthol 10 % Topical CreamSY7

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59316-869-10Biofreeze85 g in 1 JARCREAM857

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59316-869-10GM - Gram59316-869d31686b4-0888-46f4-9710-127a75a01bb612022-09-12

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59316-86959316-869-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ISOPROPYL ALCOHOLND2M416302IACT
PEG-4 LAURATEAYF4VM3N1ZIACT
GLYCERINPDC6A3C0OXIACT
CALCIUM GLUCONATESQE6VB453KIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CAPRYLYL GLYCOL00YIU5438UIACT
DIMETHICONE92RU3N3Y1OIACT
GLUCONOLACTONEWQ29KQ9POTIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 60CAL22UVI4MIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM STEAROYL LACTYLATEIN99IT31LNIACT
EDETATE SODIUMMP1J8420LUIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GRAPE SEED OIL930MLC8XGGIACT
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
BiofreezeMENTHOLReckitt Benckiser LLCa227213b-e89f-7144-e053-2a95a90a7e742026-05-13WarningsExact identifier
ndc (package): 59316-869-10
ndc (product): 59316-869
ndc11 (package): 59316086910
spl id: 51b57dbf-f47d-e694-e063-6294a90a7388
spl set id: a227213b-e89f-7144-e053-2a95a90a7e74

Reported adverse events (FAERS/openFDA)#

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