Label: BIOFREEZE ROLL-ON- menthol gel
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- NDC Code(s): 70518-0485-0
- Packager: REMEDYREPACK INC.
- This is a repackaged label.
- Source NDC Code(s): 59316-205
- 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 July 11, 2022
If you are a consumer or patient please visit this version.
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- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- 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
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PRINCIPAL DISPLAY PANEL
DRUG: Biofreeze Roll-On
GENERIC: MENTHOL
DOSAGE: GEL
ADMINSTRATION: TOPICAL
NDC: 70518-0485-0
PACKAGING: 74 mL in 1 BOTTLE
ACTIVE INGREDIENT(S):
- MENTHOL, UNSPECIFIED FORM 40mg in 1mL
INACTIVE INGREDIENT(S):
- ALOE VERA LEAF
- ARNICA MONTANA FLOWER
- FRANKINCENSE
- CALENDULA OFFICINALIS FLOWER
- GREEN TEA LEAF
- GLYCERIN
- ILEX PARAGUARIENSIS LEAF
- ISOPROPYL ALCOHOL
- ISOPROPYL MYRISTATE
- MELISSA OFFICINALIS LEAF
- SILICON DIOXIDE
- .ALPHA.-TOCOPHEROL ACETATE
- TROLAMINE
- WATER
- FD&C BLUE NO. 1
- FD&C YELLOW NO. 5
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INGREDIENTS AND APPEARANCE
BIOFREEZE ROLL-ON
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70518-0485(NDC:59316-205) 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 ALOE VERA LEAF (UNII: ZY81Z83H0X) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) FRANKINCENSE (UNII: R9XLF1R1WM) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) GREEN TEA LEAF (UNII: W2ZU1RY8B0) 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) 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:70518-0485-0 74 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/05/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 05/05/2017 Labeler - REMEDYREPACK INC. (829572556)