Label: BIOFREEZE FOOT PAIN RELIEF SET- menthol kit
- NDC Code(s): 59316-888-10, 59316-990-10
- Packager: RB Health (US) LLC
- Category: HUMAN OTC DRUG LABEL
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 21, 2021
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients:
- Uses:
-
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
- Directions:
-
Inactive Ingredients:
Caprylic/Capric Triglyceride, Cetearyl Alcohol, Diazolidinyl Urea, Dimethicone, Gluconolactone ,Glycerin, Glyceryl Stearate, Ilex Paraguariensis Leaf Extract, Iodopropynyl Butylcarbamate, Polysorbate 60, Sodium Benzoate, Sodium Hydroxide, Sodium Stearoyl Lactylate, Tetrasodium EDTA, Tocopheryl Acetate, Vitis Vinifera (Grape) Seed Oil, Water
- Questions or Comments:
- Package Labeling:KIT
- Package Labeling:
-
INGREDIENTS AND APPEARANCE
BIOFREEZE FOOT PAIN RELIEF SET
menthol kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59316-888 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59316-888-10 1 in 1 KIT 01/27/2020 12/31/2024 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 85 g Part 1 of 1 BIOFREEZE FOOT
menthol creamProduct Information Item Code (Source) NDC:59316-990 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 100 mg in 1 g Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) DIMETHICONE (UNII: 92RU3N3Y1O) GLUCONOLACTONE (UNII: WQ29KQ9POT) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) POLYSORBATE 60 (UNII: CAL22UVI4M) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN) EDETATE SODIUM (UNII: MP1J8420LU) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GRAPE SEED OIL (UNII: 930MLC8XGG) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59316-990-10 85 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/27/2020 12/31/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/27/2020 12/31/2024 Labeler - RB Health (US) LLC (081049410)