Label: BIOFREEZE FOOT PAIN RELIEF SET- menthol kit
- NDC Code(s): 59316-001-10, 59316-002-10
- 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 February 23, 2022
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 device
- Directions:
-
Inactive ingredients:
Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Dimethicone, Gluconolactone, Glycerin, Glyceryl Stearate, Hydroxyacetophenone, Ilex Paraguariensis Leaf Extract, Iodopropynyl Butylcarbamate, Phenoxyethanol, Polysorbate 60, Sodium Benzoate, Sodium Hydroxide, Sodium Stearoyl Lactylate, Tetrasodium EDTA, Tocopheryl Acetate, Vitis Vinifera (Grape) Seed Oil, Water
- Questions or comments:
- PRINCIPAL DISPLAY PANEL - 85 g Tube Kit
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INGREDIENTS AND APPEARANCE
BIOFREEZE FOOT PAIN RELIEF SET
menthol kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59316-002 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59316-002-10 1 in 1 KIT 03/12/2021 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 85 g Part 1 of 1 BIOFREEZE FOOT CREAM
menthol creamProduct Information Item Code (Source) NDC:59316-001 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) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) DIMETHICONE (UNII: 92RU3N3Y1O) GLUCONOLACTONE (UNII: WQ29KQ9POT) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) PHENOXYETHANOL (UNII: HIE492ZZ3T) 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:59316-001-10 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 03/12/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/12/2021 Labeler - RB Health (US) LLC (081049410)