BIOFREEZE PROFESSIONAL- menthol, unspecified form aerosol, spray

Biofreeze Professional by

Drug Labeling and Warnings

Biofreeze Professional by is a Otc medication manufactured, distributed, or labeled by RB Health (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Menthol 10.5%

Purpose

Pain Relieving Spray

Uses

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

• simple backache
• arthritis
• strains
• bruises
• sprains

Warnings

For external use only.

Flammable:Keep away from excessive heat or open flame

Contents under pressure. Do not puncture or incinerate.

Do not store at temperature above 120°F.

When using this product

• 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

• 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 breast-feeding,ask a health professional before use.

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

Directions

• adults and children 12 years of age and older: spray on to affected area not more than 3 to 4 times daily; massage not necessary
• children under 12 years of age: consult a physician
• wash hands after use with cool water

Other information

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

Inactive ingredients

Alcohol, Arnica Montana Flower Extract, Calendula Officinalis Flower Oil, Camellia Sinensis
Leaf Oil, Chamomilla Recutita (Matricaria) Flower Extract, Denatonium Benzoate, Echinacea
Angustifolia Extract, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate,
Juniperus Communis Fruit Extract, Methylsulfonylmethane, PurifiedWater, Tert-Butyl Alcohol

Questions or comments?

1-800-246-3733

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

CLINICALLY
RECOMMENDED*

NDC: 59316-834-20

BiOFREEZE ®
PROFESSIONAL

SPRAY
MENTHOL-PAIN
RELIEVING SPRAY

4 FL OZ (118 mL)

360°
SPRAY

PRESS DOWN FIRMLY TO
ACTIVATE SPRAYER FOR FIRST USE

INGREDIENTS AND APPEARANCE

BIOFREEZE PROFESSIONAL 
menthol, unspecified form aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59316-834
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	105 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CHAMOMILE (UNII: FGL3685T2X)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
ECHINACEA ANGUSTIFOLIA WHOLE (UNII: VB06AV5US8)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
JUNIPER BERRY (UNII: O84B5194RL)
WATER (UNII: 059QF0KO0R)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
GLYCERIN (UNII: PDC6A3C0OX)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
ISOPROPYL ALCOHOL (UNII: ND2M416302)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59316-834-20	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	02/01/2024

Labeler - RB Health (US) LLC (081049410)