BIOFREEZE OVERNIGHT 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 ® Overnight Roll-on

Drug Facts

Active

Mentol 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 ■children 2 years to under 12 years of age: use only under adult supervision

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:

Directions

adults and children 2 years of age and older:

rub a thin film over affected area not more than 3 to 4 times daily

■children under 2 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, Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Calendula Officinalis Leaf Extract, Camellia Sinensis Leaf Extract, Carbomer Interpolymer, Colloidal Silicon Dioxide, Fragrance, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Melissa Officinalis Leaf Extract, Purified Water, Tocopherol Acetate, Trolamine

Questions or Comments

1-800-246-3733

SPL UNCLASSIFIED SECTION

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

Principal Display Panel - 74 mL Bottle Label

CLINICALLY RECOMMENDED

NDC 59316-207-14

BIOFREEZE

COOL THE PAIN

ROLL-ON

MENTHOL- PAIN RELIEVING GEL

2.5 FL OZ (74mL)

SHAKE WELL BEFORE EACH USE

Label

BIOFREEZE OVERNIGHT ROLL-ON 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-207
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
GLYCERIN (UNII: PDC6A3C0OX)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
FRANKINCENSE (UNII: R9XLF1R1WM)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
ALCOHOL (UNII: 3K9958V90M)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
WATER (UNII: 059QF0KO0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59316-207-1474 mL in 1 BOTTLE; Type 0: Not a Combination Product03/16/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/16/2023
Labeler - RB Health (US) LLC (081049410)

Revised: 3/2023
Document Id: f67d7b7a-8923-73f6-e053-2995a90a2e80
Set id: f67d7b7a-8922-73f6-e053-2995a90a2e80
Version: 1
Effective Time: 20230309
 
RB Health (US) LLC