Biofreeze Foot Cream

Manufacturer
RB Health (US) LLC
Effective date
2021-12-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:21:51

Label at a glance#

ProductBiofreeze Foot
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 than 4 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 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

OTC - ASK DOCTOR SECTION

if you have: 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

OTC - DO NOT USE SECTION

• 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 than 4 times daily; massage not necessary
• Children under 12 years of age: Consult physician

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Caprylic/Capric Triglyceride, Cetearyl Alcohol, Diazolidinyl Urea, Dimethicone, Gluconolactone ,Glycerin, Glyceryl Stearate, Ilex Paraguariensis Leaf Extract, Iodopropynyl Butylcarbamate, 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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59316-99059316-990-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 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
99dcb648-61e7-49cb-a75b-974f407d3c4dfbb8570d-d45f-4a4b-a84a-4568c8df5b1f2021-12-21WarningsExact identifier
spl id: 99dcb648-61e7-49cb-a75b-974f407d3c4d
spl set id: fbb8570d-d45f-4a4b-a84a-4568c8df5b1f

Reported adverse events (FAERS/openFDA)#

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