BIOFREEZE ROLL-ON- menthol gel 
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® Roll-On

Drug Facts

Active ingredient

Menthol 4%

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, Camphor, 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 - 89 mL Bottle Carton

CLINICALLY
RECOMMENDED*

NDC 59316-205-10

BiOFREEZE®
COOL THE PAIN

ROLL-ON
MENTHOL-PAIN
RELIEVING GEL

3 FL OZ (89 mL)

SHAKE WELL
BEFORE EACH USE

PRINCIPAL DISPLAY PANEL - 89 mL Bottle Carton
BIOFREEZE ROLL-ON 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-205
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
FRANKINCENSE (UNII: R9XLF1R1WM)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
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 BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59316-205-1089 mL in 1 BOTTLE; Type 0: Not a Combination Product01/17/2013
2NDC:59316-205-1474 mL in 1 BOTTLE; Type 0: Not a Combination Product01/17/2013
3NDC:59316-205-812 in 1 CARTON02/22/2022
3NDC:59316-205-1089 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/17/2013
Labeler - RB Health (US) LLC (081049410)

Revised: 2/2022
Document Id: 4ff5f42d-b3f3-4a5e-8024-0be6ba968503
Set id: ebbbe9cb-b1ce-4dac-9fca-f54a2470c4fb
Version: 16
Effective Time: 20220217
 
RB Health (US) LLC