BIOFREEZE ROLL-ON AND OVERNIGHT ROLL-ON- menthol kit

Biofreeze Roll-On and Overnight Roll-On by

Drug Labeling and Warnings

Biofreeze Roll-On and Overnight Roll-On by is a Otc medication manufactured, distributed, or labeled by RB Health (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Roll-on/Overnight Roll-on:

Menthol 4%

Uses

Uses

Roll-on:

Temporarily relieves minor aches and pains of
muscles and joints associated with: ■ simple backache
■ arthritis ■ strains ■ bruises ■ sprains

Uses

Overnight Roll-on:

Temporarily relieves minor aches and pains of
muscles and joints associated with: ■ simple backache
■ arthritis ■ strains ■ bruises ■ sprains

WARNINGS

Warnings

Roll-on:

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

Warnings

Overnight Roll-on:

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

Directions

Directions

Roll-on:

■ 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

Directions

Overnight Roll-on:

■ 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

Questions

Questions or comments? 1-800-246-3733

KEEP OUT OF REACH OF CHILDREN

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.

PURPOSE

Purpose:

Pain Relieving Gel

INACTIVE INGREDIENT

Roll-on:

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

Overnight Roll-on:

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIOFREEZE ROLL-ON AND OVERNIGHT ROLL-ON 
menthol kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59316-209

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59316-209-14	2 in 1 KIT	04/01/2026
1		1 in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	74 mL
Part 2	1 BOTTLE	74 mL

Part 1 of 2

BIOFREEZE ROLL-ON 
menthol gel

Product Information
Item Code (Source)	NDC: 59316-205
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BLUE 1 (UNII: H3R47K3TBD)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
TROLAMINE (UNII: 9O3K93S3TK)
FRANKINCENSE (UNII: R9XLF1R1WM)
GLYCERIN (UNII: PDC6A3C0OX)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
YELLOW 5 (UNII: I753WB2F1M)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARBOMER (UNII: 0A5MM307FC)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59316-205-14	74 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/17/2013

Part 2 of 2

BIOFREEZE OVERNIGHT ROLL-ON 
menthol gel

Product Information
Item Code (Source)	NDC: 59316-207
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
FRANKINCENSE (UNII: R9XLF1R1WM)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
ALCOHOL (UNII: 3K9958V90M)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59316-207-14	74 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	03/16/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	04/01/2026

Labeler - RB Health (US) LLC (081049410)