Label: BIOFREEZE COLORLESS- menthol gel
- NDC Code(s): 50090-6361-0
- Packager: A-S Medication Solutions
- This is a repackaged label.
- Source NDC Code(s): 59316-103
- 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 13, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- 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
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, 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
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- HOW SUPPLIED
- BIOFREEZE COLORLESS
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INGREDIENTS AND APPEARANCE
BIOFREEZE COLORLESS
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-6361(NDC:59316-103) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) FRANKINCENSE (UNII: R9XLF1R1WM) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) 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) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50090-6361-0 89 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/03/2012 Labeler - A-S Medication Solutions (830016429) Establishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-6361)
