Biofreeze Foam Liquid
FDA Label NDC 59316-991

14 label sections · Submitted to the FDA by Reckitt Benckiser Llc · 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 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.

Label Section Quick Index

Other

Drug Facts

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

Active Ingredient

Menthol 7%

Purpose

Pain Relieving Liquid

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

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: rub a thin film 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

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?

1-800-246-3733

Principal Display Panel - 88 Ml Bottle Label

CLINICALLY
RECOMMENDED

NDC 59316-991-10

BIOFREEZE ®
COOL THE PAIN

FAST
DRY
FOAM

MENTHOL-PAIN
RELIEVING LIQUID

  • RUBS IN EASILY
  • LIGHTWEIGHT FEEL
  • DRIES QUICKLY

    • 3 FL OZ (88 mL)

    Principal Display Panel (88 mL Bottle Label)

    Principal Display Panel (88 mL Bottle Label)

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