BIOFREEZE DAY AND OVERNIGHT- menthol 
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 Day & Overnight Patches

Drug Facts

Menthol 5%

Pain Relieving Patch

Uses

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

■ simple backache

■ arthritis

■ strains
■ bruises

■ sprains

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

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.

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

Menthol 5%

Purpose:

Pain Relieving Patch

LabelLabel

BIOFREEZE DAY AND OVERNIGHT 
menthol kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-832
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59316-832-941 in 1 KIT05/31/2023
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 13 PATCH 18 g  in 3 
Part 26 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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM0.3 g  in 6 g
Inactive Ingredients
Ingredient NameStrength
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    
ShapeRECTANGLESize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59316-005-036 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/22/2023
Part 2 of 2
BIOFREEZE  MENTHOL
menthol, unspecified form patch
Product Information
Item Code (Source)NDC:59316-992
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM0.05 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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    
ShapeRECTANGLESize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59316-992-071 in 1 POUCH
19 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/22/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/22/2023
Labeler - RB Health (US) LLC (081049410)

Revised: 5/2023
Document Id: fc7650d7-9519-8154-e053-6294a90ac72b
Set id: fb5c8f89-a720-ad32-e053-6294a90a2abe
Version: 2
Effective Time: 20230524
 
RB Health (US) LLC