Label: BIOFREEZE PATCH MULTI PACK- menthol kit
- NDC Code(s): 59316-889-04, 59316-993-32, 59316-993-33
- 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 December 20, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients:
- Uses:
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Warnings:
For external use only
When using this product:
• Use only as directed • Avoid contact with eyes or mucous membranes • Do not apply to wounds or damaged skin • Do not use with other ointments, creams, sprays, or liniments • Do not apply to irritated skin • Wash hands after use with cool water • Do not bandage or use with heating pad or device • Store in a cool dry place away from direct sunlight
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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 patch to skin and leave in place for up to 8 hours. Use on affected
areas no more than 4 times daily. Wash hands with cool water after use
• Children under 12 years of age: Consult physician -
Inactive Ingredients:
Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Diazolidinyl Urea, Dihydroxyaluminum Aminoacetate, Glycerin, Iodopropynyl Butylcarbamate, Kaolin, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water
- Questions or Comments:
- Package Labeling:Kit
- Package Labeling:59316-993-32
- Package Labeling:59316-993-33
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INGREDIENTS AND APPEARANCE
BIOFREEZE PATCH MULTI PACK
menthol kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59316-889 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59316-889-04 1 in 1 KIT 01/30/2019 12/31/2024 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 2 PATCH 40 g in 2 Part 2 2 PATCH 26 g in 2 Part 1 of 2 BIOFREEZE
menthol patchProduct Information Item Code (Source) NDC:59316-993 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 ALOE VERA LEAF (UNII: ZY81Z83H0X) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) FRANKINCENSE (UNII: R9XLF1R1WM) GREEN TEA LEAF (UNII: W2ZU1RY8B0) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6) GLYCERIN (UNII: PDC6A3C0OX) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) KAOLIN (UNII: 24H4NWX5CO) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59316-993-32 1 in 1 POUCH 1 20 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 01/30/2019 12/31/2024 Part 2 of 2 BIOFREEZE
menthol patchProduct Information Item Code (Source) NDC:59316-993 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 ALOE VERA LEAF (UNII: ZY81Z83H0X) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) FRANKINCENSE (UNII: R9XLF1R1WM) GREEN TEA LEAF (UNII: W2ZU1RY8B0) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6) GLYCERIN (UNII: PDC6A3C0OX) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) KAOLIN (UNII: 24H4NWX5CO) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59316-993-33 1 in 1 POUCH 1 13 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 01/30/2019 12/31/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/30/2019 12/31/2024 Labeler - RB Health (US) LLC (081049410)
