Biofreeze Colorless Roll-on Gel
FDA Label NDC 59316-206

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 Colorless Roll-on (NDC 59316-206). 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:, flammable:, ask a doctor before use if you have:, when using this product:, 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 4%

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:

  • 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 or if excessive skin irritation develops.
  • Do not bandage
  • Wash hands after use with cool water
  • Do not use with heating pad or device.

Stop Use And Ask A Doctor If:

Condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur

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 than 4 times daily; massage not necessary
Children under 2 years of age: Consult physician

Other Information:

Store in a cool dry place with lid closed tightly

Inactive Ingredients:

Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Arctium Lappa Root (Burdock) Extract, Boswellia Carterii Resin Extract, Calendula Officinalis Extract, Carbomer, Camellia Sinensis (Green Tea) Leaf Extract, Camphor, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis (Lemon Balm) Leaf Extract, Silica, Tocopheryl (Vitamin E) Acetate, Triethanolamine, Water

* Please review the disclaimer below.