Active Ingredients:
Menthol 7%
Biofreeze Foam Liquid
FDA Label NDC 59316-991
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 Foam (NDC 59316-991). 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 active ingredients:, purpose, uses:, warnings:, ask a doctor before use, when using this product:, do not use, 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
Purpose
Cooling Pain Relief
Uses:
Temporary relief from minor aches and pains of sore muscles and joints associated with: • arthritis • backache • strains • 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:
• Use only as directed • Do not bandage tightly or use with heating pad or device • Avoid contact with eyes or mucous membranes • Do not apply to wounds or damaged skin
Do Not Use
• with other ointments, creams, sprays or liniments • Do not apply to irritated skin • Store at room temperature away from direct sunlight.
Stop Use And Ask A Doctor If:
Burning discomfort or excessive skin irritation develops, condition worsens, or if symptoms persist for more than 7 days, or clear up and occur within a few days
If Pregnant Or Breastfeeding:
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 12 years of age and older: Rub a thin film over affected areas not more than 4 times daily; massage not necessary
•
Children under 12 years of age: Consult physician
Inactive Ingredients:
Alcohol Denat., Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Arnica Montana Flower Extract, Bis-PEG-10 Dimethicone, Boswellia Carterii Resin Extract, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Hydroxyethyl Cetyldimonium Phosphate, Ilex Paraguariensis Leaf Extract, Isopropyl Palmitate, Melissa Officinalis Leaf Extract, PEG-12 Dimethicone,Pentylene Glycol, PPG-24-Glycereth-24, Water
Questions Or Comments:
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