Biofreeze Professional Gel
FDA Label NDC 59316-115
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Reckitt Benckiser Llc for the product Biofreeze Professional (NDC 59316-115). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredients:, purpose, uses:, warnings:, ask a doctor before use if you have:, when using this product:, stop use and ask a doctor if:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients:
Menthol USP 5%
Purpose
Cooling Pain Relief
Uses:
Temporary relief from minor aches and pains of sore muscles and joints associated with arthiritis, backache, strains and sprains
Warnings:
For external use only
Flammable: Keep away from excessive heat or open flame
Ask A Doctor Before Use If You Have:
Sensitive skin
When Using This Product:
Avoid contact with the eyes or mucous membranes; Do not apply to wounds or damaged skin; Do not use with other ointments, creams, sprays or liniment; Do not apply to irritated skin or if excessive irritation develops; Do not bandage; Wash hands after use with cool water; Do not use with heating pad or device; Store in cool dry place
Stop Use And Ask A Doctor If:
Condition worsens, or if symptoms persist for more than 7 days , or clear up and recur
If Pregnant Or Breast-Feeding:
Ask a health professional before use
Keep Out Of Reach Of Children:
If accidentally ingested, get medical help or contact a Poison Control Center immediately
Directions:
Adults and Children 2 years of age and older: Rub a thin film over affected areas not more four times daily; massage not necessary Children under 2 years of age: Consult physician
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, 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:
1-800-246-3733
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