BIOFREEZE DAY AND OVERNIGHT- menthol kit

Biofreeze Day and Overnight by

Drug Labeling and Warnings

Biofreeze Day and Overnight 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

Menthol 5%

Pain Relieving Patch

Uses

Temporarily relieves minor aches and pains of muscles and
joints associated with:

■ simple backache

■ arthritis

■ strains
■ bruises

■ sprains

WARNINGS

For external use only.

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

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

■ adults and children 12 years of age and older: Clean and dry affected area,

pop apart and partially peel back protective film and apply exposed patch to
site of pain. Carefully remove remaining film while pressing the patch to skin
and leave in place for up to 8 hours. Use on affected area not more than
3 to 4 times daily.

■ children under 12 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 INGREDIENT

Large Patch:

1,2-Hexanediol, Aloe Barbadensis Leaf Extract, Arnica Montana Flower
Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract,
Carboxymethylcellulose Sodium, DihydroxyaluminumAminoacetate, Ethylhexylglycerin,
Glycerin, Iodopropynyl Butylcarbamate, Kaolin, Mineral Oil, Petrolatum,
Phenoxyethanol, Polyacrylic Acid, Polysorbate 80, Povidone, Propylene Glycol,
PurifiedWater, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide

Overnight Relief Patch:

Benzalkonium Chloride, Carboxymethylcellulose Sodium, Dihydroxyaluminum
Aminoacetate, Edetate Disodium, Glycerin, Kaolin, Lauralkonium Chloride,
Lavender Oil, Mineral Oil, Petrolatum, Polyacrylic Acid, Polysorbate 80,
Povidone, Propylene Glycol, Purified Water, Sodium Polyacrylate,
Tartaric Acid, Titanium Dioxide

Questions

1-866-682-4639

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

PURPOSE

Menthol 5%

Purpose:

Pain Relieving Patch

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIOFREEZE DAY AND OVERNIGHT 
menthol kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59316-832

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59316-832-94	1 in 1 KIT	05/31/2023

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	3 PATCH	18 g  in 3
Part 2	6 PATCH	54 g  in 6

Part 1 of 2

BIOFREEZE OVERNIGHT RELIEF 
menthol, unspecified form patch

Product Information
Item Code (Source)	NDC: 59316-005
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	0.3 g  in 6 g

Inactive Ingredients
Ingredient Name	Strength
LAURALKONIUM CHLORIDE (UNII: 07HUP5A29X)
TARTARIC ACID (UNII: W4888I119H)
POLYACRYLIC ACID (450000 MW) (UNII: KD3S7H73D3)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
MINERAL OIL (UNII: T5L8T28FGP)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
KAOLIN (UNII: 24H4NWX5CO)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PETROLATUM (UNII: 4T6H12BN9U)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape	RECTANGLE	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59316-005-03	6 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/22/2023

Part 2 of 2

BIOFREEZE  MENTHOL
menthol, unspecified form patch

Product Information
Item Code (Source)	NDC: 59316-992
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	0.05 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PETROLATUM (UNII: 4T6H12BN9U)
GLYCERIN (UNII: PDC6A3C0OX)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
MINERAL OIL (UNII: T5L8T28FGP)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
KAOLIN (UNII: 24H4NWX5CO)
FRANKINCENSE (UNII: R9XLF1R1WM)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
POLYACRYLIC ACID (450000 MW) (UNII: KD3S7H73D3)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Product Characteristics
Color		Score
Shape	RECTANGLE	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59316-992-07	1 in 1 POUCH
1		9 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/22/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/22/2023

Labeler - RB Health (US) LLC (081049410)