Label: BIOFREEZE DAY AND OVERNIGHT- menthol kit
- NDC Code(s): 59316-005-03, 59316-832-94, 59316-992-07
- Packager: RB Health (US) LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated May 24, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- ACTIVE INGREDIENT
- Uses
-
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 deviceStop 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 presentIf 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
-
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 DioxideOvernight 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
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BIOFREEZE DAY AND OVERNIGHT
menthol kitProduct 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 patchProduct 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 patchProduct 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)