Biofreeze Professional Aerosol, Spray
FDA Label NDC 59316-834

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 59316-834). 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 other, active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Drug Facts

Dist. by: RB Health (US), Parsippany, NJ 07054-0224

Active Ingredient

Menthol 10.5%

Purpose

Pain Relieving Spray

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

For external use only.

Flammable:Keep away from excessive heat or open flame

Contents under pressure. Do not puncture or incinerate.

Do not store at temperature above 120°F.

When Using This Product

  • use only as directed
  • avoid contact with the eyes or on mucous membranes
  • do not apply to wounds or damaged skin
  • do not apply to irritated skin or if excessive irritation develops
  • do not bandage tightly or use with heating pad or device

Stop Use And Ask A Doctor If

  • you experience pain, swelling or blistering of the skin
  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • arthritic pain persists for more than 10 days, or redness is present

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding,ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • adults and children 12 years of age and older: spray on to affected area not more than 3 to 4 times daily; massage not necessary
  • children under 12 years of age: consult a physician
  • wash hands after use with cool water

Other Information

  • store at 20-25°C (68-77°F)
  • store in a cool dry place away from direct sunlight

Questions Or Comments?

1-800-246-3733

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