BIOFREEZE- menthol gel 
RB Health (US) LLC

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BiOFREEZE ®

Drug Facts

Active Ingredients:


Menthol USP 4%

Purpose

Pain Relieving Gel

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

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 breastfeeding:

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

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

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 - 473 mL Bottle Label

CLINICALLY
RECOMMENDED ®

NDC 59316-102-30

BiOFREEZE ®
COOL THE PAIN

GEL

MENTHOL-PAIN
RELIEVING GEL

16 FL OZ (1 PT) 473 mL

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
BIOFREEZE 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-102
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
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
FRANKINCENSE (UNII: R9XLF1R1WM)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
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)  
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:59316-102-105 mL in 1 BOTTLE; Type 0: Not a Combination Product01/03/2012
2NDC:59316-102-113 mL in 1 BOTTLE; Type 0: Not a Combination Product01/03/2012
3NDC:59316-102-1589 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product01/03/201212/31/2018
4NDC:59316-102-20118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/03/2012
5NDC:59316-102-25118 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product01/03/201212/31/2021
6NDC:59316-102-30473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/03/2012
7NDC:59316-102-40946 mL in 1 BOTTLE; Type 0: Not a Combination Product01/03/2012
8NDC:59316-102-503785 mL in 1 CONTAINER; Type 0: Not a Combination Product01/03/2012
9NDC:59316-102-9830 mL in 1 BOTTLE; Type 0: Not a Combination Product01/03/2012
10NDC:59316-102-8044 mL in 1 TUBE; Type 0: Not a Combination Product11/02/2018
11NDC:59316-102-1289 mL in 1 BOTTLE; Type 0: Not a Combination Product09/19/2016
12NDC:59316-102-1689 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product09/19/201612/31/2019
13NDC:59316-102-28237 mL in 1 BOTTLE; Type 0: Not a Combination Product09/19/2016
14NDC:59316-102-90100 in 1 CARTON01/03/2012
14NDC:59316-102-105 mL in 1 BOTTLE; Type 0: Not a Combination Product
15NDC:59316-102-9110 in 1 CARTON01/03/201212/31/2025
15NDC:59316-102-113 mL in 1 BOTTLE; Type 0: Not a Combination Product
16NDC:59316-102-9216 in 1 CARTON01/03/201212/31/2025
16NDC:59316-102-113 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01701/03/2012
Labeler - RB Health (US) LLC (081049410)

Revised: 11/2023
Document Id: 0a0e1685-b635-7e21-e063-6394a90a5324
Set id: 83d5c2f2-2413-4d28-83b2-0808d0917b4d
Version: 34
Effective Time: 20231113
 
RB Health (US) LLC