Biofreeze Cream
FDA Label NDC 59316-870

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 59316-870). 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 active ingredients:, purpose, uses:, warnings:, when using this product:, stop use and ask a doctor if:, if pregnant or breastfeeding:, keep out of reach of children:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients:

Menthol USP 10%

Purpose

Cooling Pain Relief

Uses:

Temporary relief from minor aches and pains of sore muscles and joints associated with: • arthritis • backache • strains • sprains •bruises

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:

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

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: rub a thin film over 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

Inactive Ingredients:


Alcohol, Calcium Gluconate, Caprylic/Capric Triglyceride,
Caprylyl Glycol, Cetostearyl Alcohol, Dimethicone, Edetate Sodium, Fragrance, Gluconolactone, Glycerin,
Glyceryl Stearate, Grapeseed Oil Refined, Hydroxyacetophenone, Ilex Paraguariensis Leaf Extract,
Iodopropynyl Butylcarbamate, Isopropyl Alcohol, PEG-4 Laurate, Phenoxyethanol, Polysorbate 60,
PurifiedWater, Sodium Benzoate, Sodium Hydroxide, Sodium Stearoyl Lactylate, Tocopheryl Acetate

Questions Or Comments:

1-800-246-3733

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