Active Ingredients:
Menthol 10.5%
Biofreeze Precision Relief Pen Liquid
FDA Label NDC 59316-830
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 Precision Relief Pen (NDC 59316-830). 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 if you have:, 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
Ask A Doctor Before Use If You Have:
Sensitive skin
Flammable: Keep away from excessive heat or open flame
When Using This Product:
• Use only as directed • 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 • Wash hands after use with cool water • Do not bandage or use with heating pad or device • Store in a cool dry place away from direct sunlight
Stop Use And Ask A Doctor If:
You experience pain, swelling or blistering; condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again 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: Press pen straight down onto affected area and hold until tip is fully soaked with liquid. Using light pressure, dab onto affected area and let dry. Repeat use not more than 4 times daily. Massage not necessary
•
Children under 12 years of age: Consult physician
Inactive Ingredients:
Alcohol Denat., Arnica Montana Flower Extract, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Dimethyl Sulfone, Echinacea Angustifolia Extract, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate, Juniperus Communis Fruit Extract, Water
Questions Or Comments:
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