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

----------

Biofreeze Professional Gel

Drug Facts

Active ingredient

Menthol 5%

Purpose

Pain Relieving Gel

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

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, or in conditions affecting children under 12 years of age

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

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?

1-800-246-3733

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

PRINCIPAL DISPLAY PANEL - 118 mL Tube Label

CLINICALLY
RECOMMENDED*

NDC 59316-115-20

BiOFREEZE ®
PROFESSIONAL

GEL
MENTHOL-PAIN
RELIEVING GEL

4 FL OZ (118 mL)

PRINCIPAL DISPLAY PANEL - 118 mL Tube Label
BIOFREEZE PROFESSIONAL 
menthol, unspecified form gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-115
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FRANKINCENSE (UNII: R9XLF1R1WM)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
GLYCERIN (UNII: PDC6A3C0OX)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59316-115-30473 mL in 1 BOTTLE; Type 0: Not a Combination Product06/03/2016
2NDC:59316-115-20118 mL in 1 TUBE; Type 0: Not a Combination Product06/03/2016
3NDC:59316-115-40946 mL in 1 BOTTLE; Type 0: Not a Combination Product06/03/2016
4NDC:59316-115-113 mL in 1 PACKET; Type 0: Not a Combination Product06/03/2016
5NDC:59316-115-503785 mL in 1 BOTTLE; Type 0: Not a Combination Product06/03/2016
6NDC:59316-115-82100 in 1 CARTON01/05/2019
63 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01706/03/2016
Labeler - RB Health (US) LLC (081049410)

Revised: 11/2023
Document Id: 0a0d9ae0-678a-3114-e063-6294a90aa085
Set id: 6bef9ccb-7a5a-4c67-b1bc-a92b167312da
Version: 11
Effective Time: 20231113
 
RB Health (US) LLC