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July 31, 2010

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Discover why quality Flexall® topical pain relieving gels are invaluable in clinical and training room settings. 

Incorporating Flexall gels into your treatment regimen will help increase “at home” patient compliance, enhance ultrasound and cryotherapy, calm the pain between T.E.N.S., and intensify soft tissue massage. Since 1987, the Flexall brand family has proven beneficial in sports medicine, injury prevention, rehabilitation, work hardening, and pain management programs.  
 
Flexall gels are among the top-selling brands in the consumer market and are well-known and trusted by patients.  Flexall gels also continue to be incorporated into the care of the world’s greatest athletes in sports programs around the world.  Flexall is used by athletes in all levels of competition including major sporting events such as The Olympics, The Super Bowl, The NBA Finals, The World Series, The Stanley Cup, college basketball tournaments, and college football bowl games. Flexall (7% menthol) and Maximum Strength Flexall (16% menthol) are unique aloe vera gel formulas with natural oils (eucalyptus, peppermint, thyme) and vitamin E.  Flexall Ultra Plus contains three active ingredients (16% menthol, 10% methyl salicylate, 3.1% camphor) in the same vitamin E-enriched aloe vera base.  Chiropractic Strength Flexall (10% menthol) is packaged exclusively for sale in the chiropractic market and is not available in mass market retail stores. 

Flexall gels provide fast, long lasting relief from minor arthritis pain, simple backache, bursitis, tendonitis, muscle strains and sprains, bruises and cramps.  Flexall gels are versatile enough to aid in treating the acute, sub-acute, and chronic stages of injury.

Patients prefer Flexall gels because they deliver fast, lasting relief; offer an effective counterirritation to pain by providing a cool sensation followed by a deeper heat; and soothe and relax sore muscles by increasing local blood flow.

The Flexall aloe vera gel formulas absorb quickly and completely, are greaseless, non-staining, and gentle on the skin.

Application Methods
Directions.  Apply generously to painful muscles and joints then gently massage until Flexall disappears.  Repeat as necessary for temporary relief of minor arthritis pain, simple backache, bursitis, tendonitis, muscle sprains and strains, bruises, and cramps.  Use before and after activity.  When treating an injured area or joint, make sure to completely coat the entire area.

Additional methods of treatment may be recommended depending upon the severity of the condition and the judgment of the health professional.

Directions For Use With Stretching.  Stretching before and after exercise is an integral part of any activity.  While much emphasis is placed on stretching before exercise, there are additional benefits realized when stretching post-activity.  Enhance all stretching sessions by applying Flexall prior to beginning.

Directions For Use With Soft Tissue Massage.  Liberally apply Flexall prior to massage.  Periodically reapply until completion of the treatment.

Directions For Use With Ultrasound.  Enhance ultrasound therapy and increase patient compliance by helping the patient “feel” the treatment.  Apply Flexall to the site prior to starting and gently massage in.  Next, perform the ultrasound treatment following established protocol.  An alternative method is to blend Flexall with a neutral coupling agent, apply this mixture to the treatment site and begin procedure.

Directions For Use With Cryotherapy.  Flexall gels can be used in any situation which normally requires the use of ice.  Completely coat the injured area with Flexall, cover with a breathable material, and apply ice. 
Warning.  Never apply ice directly to the skin or for more than 20 minutes at a time.

Directions For Use With Breathable Wraps.  As long as the material is breathable, Flexall can be used in conjunction with tape, wraps, or supports.
Warning.  Never cover an area with cellophane or other nonporous materials after applying Flexall.  In some cases, it may lead to skin irritation and blistering.

Directions For Use With Moist Heat.  Place a moist heat pack over the affected area for 5-10 minutes.  Remove heat, apply Flexall, and massage in.

Directions For Use With Electrotherapy.  Apply Flexall to help relieve painful muscles and joints between treatments on a TENS unit.  Wash the area thoroughly with soap and water prior to reattaching pads.

Treating Acute Injuries
Directions For Treating Contusions.  Liberally apply Flexall without massage.  Place an ice pack over the treated area.  Do not apply ice directly to the skin or for more than 20 minutes at a time.  Continue treatment 2-4 times per day for 2-3 days.  Add exercise to avoid loss of range of motion.  After 3 days, apply Flexall, then massage while adding heat.

Directions For Treating Sprains.  Liberally apply Flexall to the joint followed by the use of ice swabs and ice compression.  Use 2 times daily.  Continue using Flexall before contrast baths and warm whirlpools.

Directions For Treating Cramps.  Apply directly to the muscle which is cramping and massage.  In the case of an individual who is very prone to cramping, massage the area with Flexall before exercise.

Treating Chronic Injuries
The best regimen to follow is to apply Flexall directly to the injured or painful area before exercise or activity.  Upon completion, reapply Flexall in conjunction with ice.

Product Availability
 Flexall 454® is available in 0.25 oz. dispensers, 4 oz., 16 oz., 7 lb.
 Maximum Strength Flexall 454® is available in 1.5 oz., 3 oz., 16 oz., 7 lb.
 Flexall® Ultra Plus is available in 2 oz., 4 oz.

Regulatory Considerations
Flexall is formulated to stay within the guidelines established by the United States Food and Drug Administration’s tentative final monograph for external analgesics and is therefore not required to register as a new drug. According to the FDA, “…a topical analgesic or anesthetic relieves pain by depressing cutaneous sensory receptors… and a counterirritant causes irritation or mild inflammation of the skin for the purpose or relieving pain in muscles, joints or viscera distal to the site of application by stimulating cutaneous sensory receptors.” (FDA Tentative Final Monograph 21 CFR Part 348 - External Analgesic Drug Products For Over-The-Counter Human Use)

The agency classifies the Category I counterirritant active ingredients in the Flexall products as such: menthol and camphor are irritants that produce a cooling sensation, and methyl salicylate is an irritant that produces redness.

A Manufacturer’s Safety Data Sheet is available here on our website.

Ingredient Listings
Flexall 454®.  Active ingredient: Menthol (7%) in the Flexall 454 special aloe vera gel base.  Also contains allantoin, aloe vera gel, carbomer 940, eucalyptus oil, glycerin, methyl salicylate, peppermint oil, SD alcohol 38-B, steareth-2, steareth-21, thyme oil, tocopheryl acetate, triethanolamine, water.

Flexall 454® Maximum Strength.  Active ingredient: Menthol (16%) in the Flexall 454 special aloe vera gel base.  Also contains allantoin, aloe vera gel, carbomer 940, diisopropyl adipate, eucalyptus oil, glycerin, methyl salicylate, peppermint oil, SD alcohol 38-B, steareth-2, steareth-21, thyme oil, tocopheryl acetate, triethanolamine, water.

Flexall® Ultra Plus.  Active Ingredients: Menthol (16%), Methyl Salicylate (10%), Camphor (3.1%) in the Flexall special aloe vera gel base.  Also contains allantoin, aloe vera gel, carbomer 940, diisopropyl adipate, eucalyptus oil, glycerin, peppermint oil, SD alcohol 38-B, steareth-2, steareth-21, thyme oil, tocopheryl acetate, triethanolamine, water.

Chiropractic Strength Flexall 454®.  Active ingredient: Menthol (10%) in the Flexall 454 special aloe vera gel base.  Also contains allantoin, aloe vera gel, carbomer 940, diisopropyl adipate, eucalyptus oil, glycerin, methyl salicylate, peppermint oil, SD alcohol 38-B, steareth-2, steareth-21, thyme oil, triethanolamine, water.

Warnings
For external use only.  Do not bandage tightly or use a heating pad.  Keep out of reach of children.  Do not swallow.  If swallowed, call a physician or contact a poison control center immediately.  Keep away from eyes, mucous membranes, broken or irritated skin.  If skin redness or irritation develops, or pain lasts more than 10 days, discontinue use and call a physician.

Active Ingredient Compositional Breakdown
Menthol.  FDA Category I counterirritant active ingredient that produces a cooling sensation.  Considered an active ingredient when concentration levels are 1.25 to 16 percent.  Also functions as a rubefacient - brings blood to the area.
Methyl Salicylate.  FDA Category I counterirritant active ingredient that produces redness.  Considered an active ingredient when concentration levels are 10 to 60 percent.  Also functions as a rubefacient.
Camphor.  FDA Category I counterirritant active ingredient that produces a cooling sensation.  Considered an active ingredient when concentration levels are more than 3 percent up to 11 percent.  Also functions as a rubefacient.

Inactive Ingredient Compositional Breakdown
Allantoin.  Healing agent for burns and used as a skin moisturizer.
Aloe Vera Gel.  Extract from aloe vera plant leaves; a skin softener composed of 20 amino acids.  Aloe vera is claimed to have many beneficial uses including soothing burns, aiding the skin’s healing process, helping to prevent scarring and replenishing moisture.
Carbomer 940.  Thickening agent.
Diisopropyl Adipate.  Preservative.
Eucalyptus Oil.  Rubefacient.
Glycerin.  A humectant and skin softener.
Peppermint Oil.  Rubefacient.
SD Alcohol 38-B.  Denatured with 2 or more approved ingredients in accordance with 27CFR21.  Functions as a cosmetic astringent, solvent, viscosity decreasing agent.
Steareth-2.  Emulsifier.
Steareth-21.  Emulsifier.
Thyme Oil.  Rubefacient.
Tocopheryl Acetate.  Vitamin E.
Triethanolamine.  A humectant and pH controller.
Water.

Awards
 1990.  REX Retail OTC Market Maker Award

United States Distribution 
Athletic & Medical Markets
Ari-Med Pharmaceuticals   
1615 West University Drive, Suite 135
Tempe, AZ  85281-3257

Tel: 800-527-4923
Tel: 480-966-9802
Fax: 480-966-9806




Flexall 454®, Flexall 454® Maximum Strength, Flexall® Ultra Plus, Trainer’s Choice 5000®, and Ceres’ Secret® Aloe Vera Gel
are all registered trademarks of Ari-Med Pharmaceuticals.

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