Label: BIOFREEZE- menthol gel
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NDC Code(s):
59316-102-10,
59316-102-11,
59316-102-12,
59316-102-15, view more59316-102-16, 59316-102-20, 59316-102-25, 59316-102-28, 59316-102-30, 59316-102-40, 59316-102-50, 59316-102-80, 59316-102-90, 59316-102-91, 59316-102-92, 59316-102-98
- Packager: RB Health (US) LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 13, 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 Ingredients:
- Uses:
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Warnings:
For external use only
Flammable: Keep away from excessive heat or open flame
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, or in conditions affecting children under 12 years of age
- Directions:
- Other information
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Inactive Ingredients:
Aloe Barbadensis Leaf Extract, Arctium Lappa Root (Burdock) Extract, Arnica Montana Flower Extract, Blue 1, Boswellia Carterii Resin Extract, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract, Camphor, Carbomer, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis (Lemon Balm) Leaf Extract, Silica, Tocopheryl Acetate, Triethanolamine, Water, Yellow 5
- Questions or Comments:
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
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INGREDIENTS AND APPEARANCE
BIOFREEZE
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59316-102 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 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALOE VERA LEAF (UNII: ZY81Z83H0X) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) FRANKINCENSE (UNII: R9XLF1R1WM) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) GLYCERIN (UNII: PDC6A3C0OX) ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) ISOPROPYL ALCOHOL (UNII: ND2M416302) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59316-102-10 5 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/03/2012 2 NDC:59316-102-11 3 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/03/2012 3 NDC:59316-102-15 89 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 01/03/2012 12/31/2018 4 NDC:59316-102-20 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/03/2012 5 NDC:59316-102-25 118 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 01/03/2012 12/31/2021 6 NDC:59316-102-30 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/03/2012 7 NDC:59316-102-40 946 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/03/2012 8 NDC:59316-102-50 3785 mL in 1 CONTAINER; Type 0: Not a Combination Product 01/03/2012 9 NDC:59316-102-98 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/03/2012 10 NDC:59316-102-80 44 mL in 1 TUBE; Type 0: Not a Combination Product 11/02/2018 11 NDC:59316-102-12 89 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/19/2016 12 NDC:59316-102-16 89 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 09/19/2016 12/31/2019 13 NDC:59316-102-28 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/19/2016 14 NDC:59316-102-90 100 in 1 CARTON 01/03/2012 14 NDC:59316-102-10 5 mL in 1 BOTTLE; Type 0: Not a Combination Product 15 NDC:59316-102-91 10 in 1 CARTON 01/03/2012 12/31/2025 15 NDC:59316-102-11 3 mL in 1 BOTTLE; Type 0: Not a Combination Product 16 NDC:59316-102-92 16 in 1 CARTON 01/03/2012 12/31/2025 16 NDC:59316-102-11 3 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 01/03/2012 Labeler - RB Health (US) LLC (081049410)