FDA.reportPublic FDA data

Biofreeze

Manufacturer
RB Health (US) LLC
Effective date
2021-12-20
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 22:21:46

Label at a glance#

ProductBiofreeze
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure9 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: clean and dry affected area, partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing patch to skin and leave in place for up to 8 hours. Use on affected areas not more than 4 times daily. Wash hands with cool water after use. • Children under 12 years of age: Consult physician

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 5%

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

• Use only as directed • Do not bandage tightly or use with heating pad or device • Avoid contact with 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 • Store in a cool dry place away from direct sunlight

Stop use and ask a doctor if:

OTC - STOP USE SECTION

burning discomfort or excessive skin irritation develops, condition worsens, or if symptoms persist for more than 7 days, or clear up and occur within a few days

If pregnant or breast-feeding:

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: clean and dry affected area, partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing patch to skin and leave in place for up to 8 hours. Use on affected areas not more than 4 times daily. Wash hands with cool water after use.

• Children under 12 years of age: Consult physician

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Diazolidinyl Urea, Dihydroxyaluminum Aminoacetate, Glycerin, Iodopropynyl Butylcarbamate, Kaolin, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

Questions or Comments:

OTC - QUESTIONS SECTION

1-800-246-3733

Package Labeling: 59316-993-07

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label5Label5

Package Labeling: 59316-993-09

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label6Label6

Package Labeling: 59316-993-08

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagePackagePackage2Package2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59316-993-07EA - Each59316-9931a955a87-18b7-46bd-a3c8-47d11c594c4412022-06-06
59316-993-09EA - Each59316-9930702e32d-57ce-4b3e-a95b-24d14ab4e1f812022-06-06

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59316-99359316-993-07, 59316-993-09, 59316-993-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
DIHYDROXYALUMINUM AMINOACETATEDO250MG0W6IACT
GLYCERINPDC6A3C0OXIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
KAOLIN24H4NWX5COIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
TARTARIC ACIDW4888I119HIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
WATER059QF0KO0RIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB

Source Document#

Source XML · Source PDF

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
21bb2f06-3d7b-43e3-865f-d9e50ac82e51b523fe83-23f8-4aa2-9796-05fc52c1cc542021-12-20WarningsExact identifier
spl id: 21bb2f06-3d7b-43e3-865f-d9e50ac82e51
spl set id: b523fe83-23f8-4aa2-9796-05fc52c1cc54

Reported adverse events (FAERS/openFDA)#

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