Tuesday, November 13, 2012

Biofreeze®: FAQ


Q: Why did Performance Health make Biofreeze more natural?
A: We set out to make a product that delivered Biofreeze strength and efficacy . . . with a more natural ingredient list. All customers want effective pain relief and some also value a more natural ingredient profile. We are happy to report that we succeeded with both!

Q: What makes the new formula easier to apply?
A: The new formula gel is smoother and slightly thicker so it does not “ball” up as it is dispensed, making it easier to apply. An independent study validated that the new formula is indeed easier to apply and it was preferred by 4 out of 5 users.

Q: Is the new formula more natural than the previous formula?
A: Yes, the new formula contains more natural ingredients than the previous formula. The new formula uses 4% natural menthol, as opposed to 3.5% and we’ve also added a number of botanical ingredients including Arnica Montana Flower Extract (Arnica), Aloe Barbadensis Leaf Extract (Aloe), Boswellia Carterii Resin Extract (Boswellia), Calendula Officinalis Flower Extract (Calendula), Camellia Sinensis Leaf Extract (Green Tea), Arctium Lappa Root Extract (Burdock), Melissa Officinalis Leaf Extract (Lemon Balm).

Q: Why did Performance Health specifically choose the ingredients above?
A: The botanicals added were selected because of their reported functions and their connection to the use and format of Biofreeze Pain Reliever.

Q: Why did Performance Health make a colorless (dye-free) Biofreeze option? 
A: Some customers prefer products without color or dye and we want all customers to experience the pain relieving power of Biofreeze.

Q: Is dye a bad thing?
A: No. The specific colorants used in Biofreeze are on the FDA’s list—“Color Additives That Are Subject to Certification and Permitted for Use in Cosmetics”—and labeled as “acceptably used” in the governing documents. All dyes and colorants used in personal care application are strictly regulated by The FDA for safety.

Q: Are parabens dangerous? If not, why did we remove them?
A: Parabens are used to preserve formulations and protect them from spoilage, and have been used in personal care applications for more than 80 years. Although they have a strong reputation for safety, a lot of controversy surrounds parabens. Because of the controversy, some practitioners prefer a paraben-free product, if given the choice. By removing the parabens without diminishing the performance and safety characteristics of the product, we removed any need for practitioners to choose products other than Biofreeze.

Q: Are effective skin conditioners new to Biofreeze?
A: No, the previous formula included skin conditioning ingredients as well. We’re simply choosing to emphasize this with the introduction of the new formula in which we added Vitamin E and aloe.

Q: Will free samples be available in both gel and colorless gel?
A: Yes! Depending on which type a practitioners chooses to resell, we will provide free custom samples that match the practitioner’s formula preference.

Q: Was there a change to Biofreeze, Spray and Singles?
A: No. Spray and Singles have herbal ingredients, are colorless and paraben-free.

Q: What are the indications and directions for use of Biofreeze Pain Reliever?
A: Biofreeze Pain Reliever provides temporary relief from minor aches and pains of sore muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains. Apply Biofreeze Pain Reliever to the affected area not more than 4 times daily; massage not necessary.
Q: Where can I buy Biofreeze?
A: Biofreeze products are formulated for authorized distribution through hands-on healthcare practitioners for the patients, clients, and athletes under their care. To find a seller of Biofreeze in your area visit www.biofreeze.com/wheretobuy.aspx.

Q: Do I need a prescription to get Biofreeze?
A: No, you do not need a prescription, nor do you need to be a patient of a healthcare professional in your area to purchase Biofreeze from them. Biofreeze is only available through authorized dealers. Biofreeze is not available through retail outlets or pharmacy locations.
 
Q: How does Biofreeze work?
A: Biofreeze products are classified as topical analgesics, which work through a ‘counter irritant’ mechanism. This means that the menthol in Biofreeze creates a sensation that overrides pain signals to the brain. This process is known as ‘Gate Control Theory’, where nerve impulses from one stimulus block the nerves containing pain signals to the brain. Recent research also suggests that menthol may stimulate cold receptors in the skin that may help regulate pain as well.
 
Q: Is Biofreeze commonly used?
A: Yes, Biofreeze is the #1 used and recommended topical pain reliever by chiropractors, massage therapists, physical therapists, and podiatrists.

Q: How often can I use Biofreeze?
A: Biofreeze can be used up to four times a day.

Q: Can you send me a sample of Biofreeze?
A: FREE Biofreeze gel sample packets are available through healthcare practitioners in the United States, including a brochure about the product and a 5 mL trial packet. To get a free sample, find the nearest sample provider by Clicking Here.

Q: What is cryotherapy?
A: Also known as ‘cold therapy’, cryotherapy is the application of cold to temporarily relieve pain. The related term cryokinetics refers to the pairing of pain-relieving cryotherapy with exercise. This cooling and re-warming of tissue stimulates the return of blood flow to the affected areas. 
The most common form of cryotherapy is ice. Biofreeze produces the same sensation of cold that accompanies icing. But unlike ice, Biofreeze products allow you to remain active during treatment.

Q: Are there scientific studies done on Biofreeze?
A: Yes, Biofreeze conducts all FDA required studies such as: skin sensitization, drug stability, and process validation testing. We also conduct an additional battery of tests in our laboratory. Lastly, we conduct studies with clinicians to further understand our products. These studies can be found at www.thera-bandacademy.com
 
Q: Can I take Biofreeze on an airplane?
A: Yes, you can take the 2 fl oz spray, 3 fl oz roll-on, and 5 mL sample packet on an airplane.

Q: Can you give me the name of a medical distributor in my area?
A: No, we do not have access to that information. Medical distributors do not sell directly to patients and have requested that we do not give out this information. Please contact customer service to get information on distributors in your area.

Q: What sizes of Biofreeze are available to purchase by a patient?
A: Biofreeze is available in a 4 fl oz gel tube, 4 fl oz gel tube with hands-free applicator, 2 fl oz & 4 fl oz spray, 3 fl oz roll-on, or 5 ml trial packets.
o The 4 fl oz Biofreeze gel tube is particularly well-suited for hands-on massage applications of larger muscle areas.
o The 4 fl oz Biofreeze gel tube with hands-free applicator allows the user to apply the gel either hands-free or hands-on. The delicate sponge applicator is perfect for even application of Biofreeze on sore joint, especially smaller joints like the knuckles.
o  The 3 fl oz Biofreeze roll-on is a hands-free application with the added benefit of the roller ball that can be used to massage painful muscles and stimulate trigger points in the affected area.
o The 2 fl oz & 4 fl oz Biofreeze Spray is hands-free application designed for hard to reach areas and is particularly beneficial for conditions involving minor neck and back pain.
o The 5 mL packets are available in boxes of 100 and are most commonly used for traveling purposes, when it is inconvenient to carry one of the larger sizes.

Q: Can I buy the larger bottle sizes of the Biofreeze?
A: The larger sizes of Biofreeze are designed for in clinic use.  Please consult a healthcare practitioner regarding the purchase of professional sizes.

Q: Is Biofreeze available in stores or through the Internet?
A: Biofreeze is only sold through hands-on healthcare professionals, not in retail stores. Some clinicians do sell Biofreeze on through their website. To locate a practitioner in your area please go to www.biofreeze.com/wheretobuy

Q: Do you have any studies about long-term use of Biofreeze?
A: Biofreeze is an over the counter topical analgesic pain relieving gel used to provide temporary relief from minor aches and pains of sore muscles and joints associated with simple backache, arthritis, bruises, strains and sprains. It is labeled according to the Food and Drug Administration (FDA) regulations regarding topical analgesics. All ingredients, directions for use, and product warnings are listed on the label.
Please remember that Biofreeze is a topical pain reliever, not a cure to an underlying condition. It provides temporary pain relief. If you have any questions regarding the product or its use, please consult your healthcare Professional. If condition worsens or symptoms persist for more than 7 days consult a doctor.
 
Q: How long does Biofreeze last, when is the expiration date?
A: The product’s shelf life is 2 years. The expiration date can be located on the package of Biofreeze Pain Relieving Product.

Q: What is the active ingredient in Biofreeze?
A: The active ingredient in Biofreeze is menthol.

Q: When was Biofreeze invented?
A: Biofreeze was first introduced in 1991 by a healthcare practitioner that was searching for a way to help his grandmother manage her arthritis pain. Today, Biofreeze products provide relief to countless arthritis sufferers. But the pain reliever’s unique, cooling formulation is also comforting to sore muscles and muscle sprains; easing back shoulder and neck pain; reducing painful ankle, knee, hip, and elbow joints and helping to lessen the effects of muscular strain.

Q: Does the new formula contain gluten, starch, aspirin or nut derivatives?
A: No

Q: Will Biofreeze cause any adverse effects if I am taking other medications?
A: Biofreeze is only a topical pain reliever and has a low potential for absorption. We do suggest that you always check with your healthcare professional before using Biofreeze.

Q: If I am Pregnant or nursing – Can I use Biofreeze?
A: Consult a healthcare professional before use.

Q: Can I use a heating pad while also using Biofreeze?
A: No, you should never use a heating pad while using Biofreeze. Biofreeze works by causing a cooling effect, not heat. By using a heating pad in conjunction with Biofreeze, you may cause serious injury to yourself. You may not be able to tell how hot the heating pad is on the problem area, even possibly causing yourself to experience severe blistering.

Q: Can I wrap the area where I have used the Biofreeze?
A: No. You should not wrap or bandage the area where Biofreeze is being applied.

Q: Biofreeze in the EYE – how should I treat this?
A: Tell your patient to rinse his/her eyes with lukewarm water or to take a warm shower with the shower water hitting their forehead and running down through their eyes. Do this for 15 minutes. If problem persists, have them see a physician and be sure they take the Biofreeze with them.


Q: Can I use Biofreeze to cool sunburn pain, in a tanning bed or sauna?
A: Biofreeze is not intended for use in these types of situations.
 
Q: Can I use Biofreeze on insect bites or for poison ivy?
A: Biofreeze is not intended for use in these types of situations.

Q: Will Biofreeze work on headaches?
A: Biofreeze is not intended for this use.

Q: My child or pet ate Biofreeze, what do I do?
A: If your child placed it in mouth but did not swallow, flood mouth with lukewarm water and rinse out mouth thoroughly.
If your child swallowed Biofreeze, drink several glasses of water, and DO NOT induce vomiting. If a large amount is consumed, contact a Poison Control Center immediately.
Pet – Contact your veterinarian immediately. Animals will not drink water on command. Animals have a highly developed sense of smell and the menthol, camphor and alcohol contact will warn them away from ingesting the product. It overwhelms their sense of smell and therefore, does not appear as food or something appetizing. Biofreeze should not hurt them, but it is always best to contact your veterinarian in any instance where Biofreeze has been ingested by your pet.

Q: Can I use Biofreeze on an open wound or stitches?
A: No, do not apply to wounds or damaged skin.

Q: After applying Biofreeze, I have developed a rash/irritation on my skin. What should I do?
A: Take a tepid (warm) bath with one cup of Arm and Hammer baking soda, or other brand of baking soda. Relax for at least 20 minutes. If rash persists, contact your physician.

Q: Is Biofreeze registered with the FDA?
A: Yes, The FDA registers the facilities that manufacture Biofreeze. Please refer to the National Drug Code number that is on every Biofreeze product. This number represents to the FDA, our product/brand and the actual size of the container.
 
Q: Is there Aspirin in Biofreeze?
A: No

Q: Is there Capsaicin in Biofreeze?
A: No

Q: Can I use Biofreeze if I have Diabetes?
A: Yes, Biofreeze is a topical pain reliever has a low potential for absorption. Diabetes is a disease in which the body cannot use sugar normally. When diagnosed with this particular ailment, you must be extremely cautious when using any OTC medications. There are certain ingredients in OTC medications that do go in to the bloodstream that can cause a severe reaction to the Diabetic patient. Biofreeze does not contain any of these ingredients and can often be used by the diabetic patient. However, please consult with your healthcare professional before use of the product.
 
Q: Is Biofreeze vegetarian friendly?
A: Yes Biofreeze is vegetarian friendly, no animal products are used in the ingredients. Biofreeze is also not animal tested.

How Biofreeze® Work: Mechanism of Action


Traditional thinking is that the pain-relieving mechanism of action of menthol - the active ingredient in Biofreeze Pain Reliever - results from a counter-irritant effect. Simply put, a counter-irritant has an effect of overriding noxious pain signals traveling to the brain through a process modulated between pain-transmitting and non-pain transmitting neurons. This process, known as "gate control" or "gating," was first described by Melzak and Wall.
  
Gate control theory is based on the understanding that pain is transmitted by two kinds of afferent nerve fibers. One is the larger myelinated A-delta fiber, which carries quick, intense-pain messages. The other is the smaller, unmyelinated "C" fiber, which transmits throbbing, chronic pain. A third type of nerve fiber, called A-beta, is "nonnociceptive," meaning it does not transmit pain stimuli. The gate control theory asserts that signals transmitted by the A-delta and C pain fibers can be thwarted by the activation/stimulation of the nonnociceptive A-beta fibers and thus inhibit an individual's perception of pain.
 
More recently, laboratory researchers have discovered that menthol stimulates the TRPM8 cold receptors. Even though it has long been accepted that cooling and cold can induce analgesia it has been a poorly understood mechanism. As scientists have continued to isolate these specific heat-sensitive transient receptor potential (TRP) channels within our sensory neurons we are now able to have a much better understanding of the body's cutaneous temperature detection. With the isolation and further study of these specific TRPM8 receptors there is stronger evidence supporting the benefits achieved with the cooling effect of menthol in functioning as a topical analgesic while activating these receptors and the resulting consequent pain relief.

The History of Biofreeze®

Biofreeze was first introduced to the world by a medical professional who was searching for a way to help his grandmother manage her arthritis pain. The formula he created consisted of the active ingredient menthol with a synergistic blend of inactive ingredients. The resulting formula offered quick, effective pain relief without the use of prescription drugs.
 
Today, Biofreeze products are providing relief to countless arthritis sufferers. But the pain reliever's unique, cooling formulation is also comforting to sore muscles and muscle sprains; easing back, shoulder and neck pain; reducing painful ankle, knee, hip and elbow joints and helping to lessen effects of muscular strains.
 
The company that launched Biofreeze was Performance Health, Inc. This company was acquired by the Hygenic Corporation in 2006. The Hygenic Corporation is located in Akron, Ohio and serves the hands-on healthcare professional markets with pain management solutions and with its Thera-Band brand product portfolio of Systems of Trusted Progression.