Biofreeze Professional Gel

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 5%

Purpose

OTC - PURPOSE SECTION

Pain Relieving Gel

Uses

INDICATIONS & USAGE SECTION

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

• simple backache
• arthritis
• strains
• bruises
• sprains

Warnings

WARNINGS SECTION

SPL UNCLASSIFIED SECTION

For external use only.

SPL UNCLASSIFIED SECTION

Flammable: Keep away from excessive heat or open flame

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, or in conditions affecting children under 12 years of age

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• adults and children 2 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily
• children under 2 years of age: consult a physician
• wash hands after use with cool water

Other information

STORAGE AND HANDLING SECTION

• store at 20-25°C (68-77°F)
• store in a cool dry place away from direct sunlight

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Arctium Lappa Root (Burdock) Extract, Arnica Montana Flower Extract, Blue 1, Boswellia Carterii Resin Extract, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract, Carbomer, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis (Lemon Balm) Leaf Extract, Silica, Tocopheryl Acetate, Triethanolamine, Water, Yellow 5

Questions or comments?

OTC - QUESTIONS SECTION

1-800-246-3733

SPL UNCLASSIFIED SECTION

Dist. by: RB Health (US), Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 118 mL Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CLINICALLY
RECOMMENDED*

NDC 59316-115-20

BiOFREEZE ^®
PROFESSIONAL

GEL
MENTHOL-PAIN
RELIEVING GEL

4 FL OZ (118 mL)

DailyMed RxNorm Mappings#

DailyMed Package Descriptions#

DailyMed Billing Units#

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

• Biofreeze Professional
• MENTHOL, UNSPECIFIED FORM
• ALOE VERA LEAF
• ARCTIUM LAPPA ROOT
• ARNICA MONTANA FLOWER
• FD&C BLUE NO. 1
• FRANKINCENSE
• CALENDULA OFFICINALIS FLOWER
• GREEN TEA LEAF
• CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
• GLYCERIN
• ILEX PARAGUARIENSIS LEAF
• ISOPROPYL ALCOHOL
• ISOPROPYL MYRISTATE
• MELISSA OFFICINALIS LEAF
• SILICON DIOXIDE
• .ALPHA.-TOCOPHEROL ACETATE
• TROLAMINE
• WATER
• FD&C YELLOW NO. 5

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 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.

Reported adverse events (FAERS/openFDA)#

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