Biofreeze Spray
FDA Label NDC 59316-835

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rb Health (us) Llc for the product Biofreeze (NDC 59316-835). 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 using 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

Purpose:

Pain Relieving Spray

Flammable:

Keep away from excessive heat or open flame.

Ask A Doctor Before Using If You Have:

■ 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

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 Breast-Feeding:

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

* Please review the disclaimer below.