Biofreeze Flexible Relief Strip Patch
FDA Label NDC 59316-004

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 Flexible Relief Strip (NDC 59316-004). 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:, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients:

Menthol 5.6%

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

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
  • Do not overwrap or wrap strips over themselves
  • 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: Clean and dry affected area, partially peel back protective film and apply exposed strip to site of pain. Carefully remove remaining film while pressing the strip to the skin and leave in place for up to 8 hours. Do not stretch the strip during application as it should be comfortable and not tight. Use on affected areas not more than 4 times daily. For best adhesion: area should be clean, dry, and smooth 
  • Children under 12 years of age: Consult physician

Inactive Ingredients:

Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Benzalkonium Chloride, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Isopropyl Myristate, Kaolin, L-Tartaric Acid, Lauralkonium Chloride, Mineral Oil, Nonoxynol-10, Petrolatum, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, PVP, Sodium Polyacrylate, Titanium Dioxide, Water

Questions Or Comments:

1-800-246-3733

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