BIOFREEZE PROFESSIONAL- menthol, unspecified form spray 
RB Health (US) LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Biofreeze® Professional Spray

Drug Facts

Active ingredient

Menthol 10.5%

Purpose

Pain Relieving Spray

Uses

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

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

Other information

Inactive ingredients

Alcohol Denat., Arnica Montana Flower Extract, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Dimethyl Sulfone (MSM), Echinacea Angustifolia Extract, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate, Juniperus Communis Fruit Extract, Water

Questions or comments?

1-800-246-3733

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

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

CLINICALLY
RECOMMENDED*

NDC 59316-120-20

BiOFREEZE®
PROFESSIONAL

SPRAY
MENTHOL-PAIN
RELIEVING SPRAY

4 FL OZ (118 mL)

360°
SPRAY

PRESS DOWN FIRMLY TO
ACTIVATE SPRAYER FOR FIRST USE

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
BIOFREEZE PROFESSIONAL 
menthol, unspecified form spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-120
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM105 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59316-120-30473 mL in 1 BOTTLE; Type 0: Not a Combination Product06/03/2016
2NDC:59316-120-20118 mL in 1 BOTTLE; Type 0: Not a Combination Product06/03/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/03/2016
Labeler - RB Health (US) LLC (081049410)

Revised: 5/2022
Document Id: fc1f8b61-3ba1-4976-9eb1-ca9993f4478f
Set id: db982baf-31ea-4f09-90e3-cd5facb5dfe5
Version: 10
Effective Time: 20220520
 
RB Health (US) LLC