Biofreeze Overnight Relief Cream

Manufacturer
Reckitt Benckiser LLC
Effective date
2026-05-13
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:57:38

Label at a glance#

ProductBiofreeze
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure6 sections

Indications and uses

Temporary relief from minor aches and pains of sore muscles and joints associated with: • arthritis • backache • strains • sprains •bruises For external use only ■ 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 Condition ...

Dosage and administration

■ adults and children 12 years of age and older : rub a thin film over affected area not more than 3 to 4 times daily ■ children under 12 years of age: consult a physician ■ wash hands after use with cool water

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 •bruises

Warnings:

WARNINGS SECTION

For external use only

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

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 area not more
than 3 to 4 times daily
■ children under 12 years of age: consult a physician


■ wash hands after use with cool water

Inactive Ingredients:

INACTIVE INGREDIENT SECTION


Alcohol, Calcium Gluconate, Caprylic/Capric Triglyceride,
Caprylyl Glycol, Cetostearyl Alcohol, Dimethicone, Edetate Sodium, Fragrance, Gluconolactone, Glycerin,
Glyceryl Stearate, Grapeseed Oil Refined, Hydroxyacetophenone, Ilex Paraguariensis Leaf Extract,
Iodopropynyl Butylcarbamate, Isopropyl Alcohol, PEG-4 Laurate, Phenoxyethanol, Polysorbate 60,
PurifiedWater, Sodium Benzoate, Sodium Hydroxide, Sodium Stearoyl Lactylate, Tocopheryl Acetate

Questions or Comments:

OTC - QUESTIONS SECTION

1-800-246-3733

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

RECENT MAJOR CHANGES SECTION

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2001133BIOFREEZE 10 % Topical CreamPSN8
253020menthol 10 % Topical CreamPSN8
2001133menthol 100 MG/ML Topical Cream [Biofreeze]SBD8
253020menthol 100 MG/ML Topical CreamSCD8
2001133Biofreeze 10 % Topical CreamSY8
2001133Biofreeze 100 MG/ML Topical CreamSY8
253020menthol 10 % Topical CreamSY8

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59316-870-10Biofreeze85 g in 1 JARCREAM858

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59316-870-10GM - Gram59316-8702dab596e-2e5c-4a5b-8d1d-8728f194255f12024-08-12

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
59316-87059316-870-10

Ingredients#

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

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

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 LLC10a8face-47da-ebbe-e063-6294a90a42fe2026-05-13WarningsExact identifier
ndc (package): 59316-870-10
ndc (product): 59316-870
ndc11 (package): 59316087010
spl id: 51b574d1-9ee5-b2aa-e063-6294a90a5a3f
spl set id: 10a8face-47da-ebbe-e063-6294a90a42fe

Reported adverse events (FAERS/openFDA)#

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