Transanosil

Physicians Science & Nature Inc.

Transanosil Topical Pain Relief Lotion

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active Ingredients
• Purpose
• Transanosil Uses
• Warnings
• Keep away from children.
• Directions:
• Do Not Use:
• Stop Use and Ask a Physician:
• Inactive Ingredients
• Package Insert
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active Ingredients

Methyl Salicylate 30%

Menthol 10%

Capsaicin 0.025%

Purpose

Topical Analgesic

Transanosil Uses

For temporary relief of mild pain due to muscular strain, arthritis, and simple back pain. Does not cure any disease.

Warnings

For external use only. Do not use in eyes, mouth, on mucus membranes, or genitals. Do not tightly bandage. Do not use with heating pad. Do not use with other topical pain products.

Keep away from children.

Directions:

Use only as directed. Shake before each use. Prior to first use rug small amount to check for sensitivity. Gently rub over painful areas. Dry before contact with clothes or bedding to avoid staining. Wash hands after use. Do not use more than 4 times daily or if pregnant or nursing. If swallowed, call poison control. If placed into eyes, rinse with cold water and call a doctor.

Do Not Use:

On cuts or infected skin, on children less than 12 years old, in large amounts, especially over raw or blistered skin, if allergic to any ingredients, PABA, aspirin products, or sulfa. Store below 90°F/32°C

Stop Use and Ask a Physician:

For severe undiagnosed pain. If pain worsens or persist for more than 7 days. If pain clears up and then recurs in a few days. If itching or rash occurs.

Inactive Ingredients

water, benzocaine, glyceryl stearate, PEG 100 stearate, stearic acid, cetyl alcohol, propylene glycol, dimethyl sulfoxide, triethanolamine, poloxamer 407, aloe barbadensis gel, borage oil, ammoniumacryloydimethyltaurate/VP copolymer, zingiber officinale root extract, methylparaben, propylparaben, soya lethicin, DMDM hydantoin, sodium stearoyl glutamate.

Manufactured for: Physician's Science and Nature, Inc.

220 Newport Center Drive 11-634
Newport Beach, CA 92660

Made in USA
Patent Pending

Package Insert

Transanosil, an over-the-counter (OTC)  topical medication is a unique blend of pharmaceutical medications combined with naturally occurring remedies that have been used for centuries to provide a powerful formulation for pain control.
All of the naturally occurring products contained in Transanosil have been shown to be effective in scientific studies to reduce inflammation and relieve pain.^1,2,3,4 Pain relief is achieved as a result of the combined analgesic, anti-inflammatory, and anesthetic properties of this formulation formulated with skin penetrant enhancers. Clinical studies conclude that Transanosil effectively reduces pain and increases function compared to placebo. No other topical pain relief formula has more pain relieving components than Transanosil. No other topical pain relieving formula has been shown to be more effective than Transanosil. Transanosil is non- allergic in human use studies. Transanosil was created by a physician with over 30 years of experience who has dedicated his practice to the management of pain conditions. This formula is the result of years of research to find the most effective topical pain relieving formula.

Indications of Use: This formula can be helpful in the treatment of painful muscles due to acute or chronic musculoligamentous strain, joint pain due to acute or chronic bursitis, tendonitis or osteoarthritis, and nerve pain due to acute or chronic neuropathies such as post herpetic neuralgia, peripheral neuropathies such as diabetic neuropathy and complex regional pain syndrome or RSD. Transanosil can even be used to treat some types of headaches such as tension cephalgia (caution is advised to avoid eye contact). Before using Transanosil please carefully read the product information and follow the directions and precautions on the label.

Directions for use: Use only as directed. Prior to first use, rub a small amount into the forearm to check for sensitivity. The usual topical dose depends on the extent of the pain. However, the usual dose is up to 5 gm, about the size of a quarter, applied four times daily. Gently rub over affected area. Do not massage vigorously. One 60 ml bottle usually lasts about 2 weeks. For external use only. Wash hands after use. If accidently placed in eyes, on genitalia or if painful burning sensation occurs rinse thoroughly with cold, clean water.

Adverse Reactions: While adverse reactions are rare, 2% of patient report an unpleasant burning sensation. Rash or allergic reaction develops in less than 1%. To test for allergy to Transanosil apply a small amount on the forearm prior to first use. Although there have been reports in the literature of severe burns in some patients with topical use of methyl salicylate and menthol medications, no such severe reactions have been reported with Transanosil. No systemic effects have been reported. If any ill effects occur Transanosil should be discontinued immediately and treated appropriately by a trained health care professional if necessary.

Do not use if under 2 years old, pregnant or nursing, with other topical pain products including pain relief patches, in the eyes, on mucous membranes, on genitalia, over large areas of the body on infected, blistered or broken skin, with heating pads, if allergic to any of the ingredients, if redness or a rash develops, or longer than one week unless directed by a physician.

Stop use and consult a physician if  symptoms persist or worsen, symptoms clear up and then recur within a few days, symptoms last more than 7 days, a fever occurs, if lethargy, itching, rash, swelling, difficulty breathing or other allergic reaction occurs. If undiagnosed pain persists or worsens.

Warnings: Do not eat, swallow, or use internally. Keep out of reach of small infants, children or animals. Contact poison control center right away if swallowed. Do not apply under tight bandages. Store at room temperature. Do not expose to extremes of temperature. Allow to dry before dressing or sleeping or to avoid staining of cloths or bedding. Do not place on furniture to avoid damage to furniture surfaces.

 Inactive Ingredients:

Aloe barbadensis gel, ammoniumacrloyldimethyltaurate/VP, benzocaine, borage oil, cetyl alcohol, copolymer, DMDM hydantoin, dimethyl sulfoxide, distilled water, glyceryl stearate, methylparaben, PEG 100 stearate, propylene glycol, propylparaben, poloxamer 407, sodium stearoyl glutamate, soya lecithin, steraric acid, triethanolamine, zingiber offinate (ginger) root extract.

Manufactured in the USA for Physician’s Science and Nature, Inc., 220 Newport Center Drive Ste. 11-634, Newport Beach California, 92660 USA.

^1. Dunteman E. Targeted peripheral analgesics in Chronic Pain Syndromes. Practical Pai Management. 2005; July/August:14-25
^2.Jones M. Chronic neuropathic pain: Pharmacologic interventions in the new millennium. A theory of efficacy. International J Pharmaceutical Compounding. 2004(1):6-15
^3. Sawynok J. Topical and peripherally acting analgesics. Pharmacology Reviews. 2003;55(1):1-20
^4. Moore R.A., et. al., Quantitive systemic review of topically applied non-steroidal anti-inflammatory drugs. British Medical Journal. 1998;316:333-338
^5. National Library of Medicine Daily Med website - htttp://dailymed.nlm.nih.gov/dailymed/about.cfm

Principal Display Panel

Physician's Science and Nature, Inc.

Transanosil^™

New Formula
Professional Formula

Topical Pain Relief Lotion
Deep Penetrating Action

120 ml (4 fl oz)

NDC 2749501804