Biofreeze Spray
FDA Label NDC 59316-104

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 59316-104). 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:, flammable:, ask a doctor before use if you have:, when using this product:, stop use and ask a doctor if:, 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 Reliever

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 the eyes or mucous membranes - Do not apply to wounds or damages skin  -Do not use with other ointments, creams, sprays or liniments -Do not apply to irritated  skin or if excessive 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 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 / Children 12 years and older: Apply on to affected area up to 4 times daily

Children under 12 years of age: Consult a physician

Other Information:

Store in a cool dry place with lid closed tightly

Inactive Ingredients:

Arnica Montana, Calendula,Chamomile, Dimethyl Sulfone (MSM), Echinacea, Ethanol,  Lex Paraguarenis, Isopropyl Myristate, Juniper Berry, Purified Water USP, White Tea

Questions Or Comments?

1-800-246-3733

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