Label: BIOFREEZE PRECISION RELIEF PEN- menthol liquid
- NDC Code(s): 59316-830-37, 59316-830-38
- 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 January 18, 2022
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
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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
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Directions
- adults and children 12 years of age and older: shake well before use. Press pen straight down onto affected area and hold until tip is fully soaked with liquid. Using light pressure, dab onto skin and let dry. Apply to affected area not more than 3 to 4 times daily; massage not necessary
- children under 12 years of age: consult a physician
- wash hands after use with cool water
- Other information
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Inactive ingredients
Alcohol Denat., Arnica Montana Flower Extract, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Dimethyl Sulfone (MSM), Echinacea Angustifolia Extract, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate, Juniperus Communis Fruit Extract, Water
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 34 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
BIOFREEZE PRECISION RELIEF PEN
menthol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59316-830 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 105 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CHAMOMILE (UNII: FGL3685T2X) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) ECHINACEA ANGUSTIFOLIA WHOLE (UNII: VB06AV5US8) ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) JUNIPER BERRY (UNII: O84B5194RL) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59316-830-37 34 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/31/2020 2 NDC:59316-830-38 1 in 1 CARTON 12/31/2020 2 34 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 not final part348 12/31/2020 Labeler - RB Health (US) LLC (081049410)