Biofreeze Kit
FDA Label NDC 59316-887

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 (NDC 59316-887). 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

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel - Kit Carton

Other

Drug Facts

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

Active Ingredient

Menthol 5%

Purpose

Pain Relieving Patch

Uses

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

simple backache
arthritis
strains
bruises
sprains

Warnings

For external use only.

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: Clean and dry affected area, pop apart and partially peel back protective ﬁlm and apply exposed patch to site of pain. Carefully remove remaining ﬁlm while pressing the patch to skin and leave in place for up to 8 hours. Use on affected area not more than 3 to 4 times daily.
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

Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Cellulose Gum, Dihydroxyaluminum Aminoacetate, Ethylhexylglycerin, Glycerin, Iodopropynyl Butylcarbamate, Kaolin, Mineral Oil, Phenoxyethanol, Petrolatum, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water