Label: BIOFREEZE OVERNIGHT GEL- menthol gel
- NDC Code(s): 59316-121-10
- 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 28, 2023
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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 •Children 2 years to under 12 years of age:Use only under adult supervision
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
If pregnant or breastfeeding:
Ask a health professional before use
Keep out of reach of children:
If swallowed, get medical help or contact a Poison Control Center right away
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Inactive Ingredients
Inactive ingredients
Alcohol, Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Calendula Officinalis Leaf Extract, Camellia Sinensis Leaf Extract, Carbomer Interpolymer, Fragrance, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Melissa Officinalis Leaf Extract, Purified Water, Tocopherol Acetate, Trolamine
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INGREDIENTS AND APPEARANCE
BIOFREEZE OVERNIGHT GEL
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59316-121 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) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ISOPROPYL ALCOHOL (UNII: ND2M416302) MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) WATER (UNII: 059QF0KO0R) TROLAMINE (UNII: 9O3K93S3TK) FRANKINCENSE (UNII: R9XLF1R1WM) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) GREEN TEA LEAF (UNII: W2ZU1RY8B0) ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59316-121-10 89 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/01/2023 Labeler - RB Health (US) LLC (081049410)
