Biofreeze Foot Pain Relief Set

Manufacturer
Reckitt Benckiser LLC
Effective date
2026-05-13
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:57:40

Label at a glance#

ProductBiofreeze Foot Pain Relief Set
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure7 sections

Indications and uses

Temporarily relieves minor aches and pains of muscles and joints associated with: • arthritis • simple backache • strains • sprains • bruises

Dosage and administration

• Adults and Children 12 years of age and older: Rub a thin film over affected areas 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 ingredient:

OTC - ACTIVE INGREDIENT SECTION

Menthol 10%

Purpose

OTC - PURPOSE SECTION

Pain Relieving Cream

Uses:

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and pains of muscles and joints associated with: • arthritis • simple 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

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

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 right away

Directions:

DOSAGE & ADMINISTRATION SECTION

• Adults and Children 12 years of age and older: Rub a thin film over affected areas 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

Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Dimethicone, Gluconolactone, Glycerin, Glyceryl Stearate, Hydroxyacetophenone, Ilex Paraguariensis Leaf Extract, Iodopropynyl Butylcarbamate, Phenoxyethanol, Polysorbate 60, Sodium Benzoate, Sodium Hydroxide, Sodium Stearoyl Lactylate, Tetrasodium EDTA, Tocopheryl Acetate, Vitis Vinifera (Grape) Seed Oil, Water

Questions or comments:

OTC - QUESTIONS SECTION

1-800-246-3733

PRINCIPAL DISPLAY PANEL - 85 g Tube Kit

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 59316-002-10

BiOFREEZE ®
COOL THE PAIN

FOOT PAIN
RELIEF SET

MENTHOL-PAIN
RELIEVING CREAM

FOOT ROLLER intended to
relieve foot pain and pain associated
with plantar fasciitis

1 Biofreeze Foot Cream Tube
Net wt 3 OZ (85 g)
+ 1 Foot Roller

PRINCIPAL DISPLAY PANEL - 85 g Tube Kit
PRINCIPAL DISPLAY PANEL - 85 g Tube Kit

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2001133BIOFREEZE 10 % Topical CreamPSN6
253020menthol 10 % Topical CreamPSN6
2001133menthol 100 MG/ML Topical Cream [Biofreeze]SBD6
253020menthol 100 MG/ML Topical CreamSCD6
2001133Biofreeze 10 % Topical CreamSY6
2001133Biofreeze 100 MG/ML Topical CreamSY6
253020menthol 10 % Topical CreamSY6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59316-001-10Biofreeze Foot Pain Relief Set85 g in 1 TUBECREAM85 g100 mg in 1g6
59316-002-10Biofreeze Foot Pain Relief Set1 in 1 KITKIT16

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59316-00259316-002-10
59316-00159316-001-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Biofreeze Foot CreamMENTHOLReckitt Benckiser LLC32450cbf-4ed4-402b-a30e-e08a17bba3fb2026-05-13WarningsExact identifier
ndc (package): 59316-001-10
ndc (product): 59316-001
ndc11 (package): 59316000110
Biofreeze Foot Pain Relief SetMENTHOLReckitt Benckiser LLC4a885eef-0364-4655-bccc-7158c76cc5b22026-05-13WarningsExact identifier
ndc (package): 59316-002-10
ndc (package): 59316-001-10
ndc (product): 59316-002
ndc11 (package): 59316000110
ndc11 (package): 59316000210
spl id: 51b58d16-badb-06b8-e063-6294a90a94ea
spl set id: 4a885eef-0364-4655-bccc-7158c76cc5b2

Reported adverse events (FAERS/openFDA)#

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