Aone

1. Introduction: - BOTULAX, Botulinum Toxin A is the number one non surgical cosmetic procedure for both men and women which is produced from fermentation of Hall strain Clostridium. - Botulax 100 iu contains 100 units (U) of Clostridium botulinum toxin type A, 0.5 milligrams of albumin (human)and 0.9 milligrams of sodium chloride in a sterile, vacuum-dried from without a preservative. 2. Active ingredient: - Clostridium botulinum toxins type A (100 units). - Stabilizer: Human serum albumin 0.5mg - Tonic Adjuster: Sodium chloride (KP) 0.9mg 3. Mode of action: - Botulinum Toxin Type A blocks signals from the nerves to the muscles. - The injected muscle can no longer contract, which causes the wrinkles to relax and soften. - It is most often used on forehead lines, crow’s feet (lines around the eye) and frown lines. 4. Effectiveness: - Botulax 100 iu guarantees high patient satisfaction. - Potency variation is strictly controlled to within 91-115 units/ vial, more stringent than the legally required range. - Size of toxin complex is 900kDa, minimize spread of botulinum toxin outside of the injection site. - Such large and homogeneous size of the toxin complex ensures precise and uniform effect at the time of injection, guaranteeing high patient satisfaction with Botulax 100 IU. 5. Shelf Life: 3 years in freeze-drying conditions 6. Storage: Store at temperature of +2 to +8°C Botulax contains 100 units (U) of Clostridium botulinum toxin type A, 0.5 milligrams of albumin (human)and 0.9 milligrams of sodium chloride in a sterile, vacuum-dried from without a preservative. Botulinum toxin type A neutroxin: purified from Clostridium botulinum type A Albumin: Human serum albumin,bulking and stabilizing agent and adhesion reducer. KP grade NaCl: Bulking agent and keeping isotonicity during formulation KP grade Developmental status: 2007.5: reported nonclinical study 2008.3: reported clinically study Phase l 2009.7: Finished Phase lll clinically study Characteristics of Botulax:Higher specific activity than those of other company’s botolinum toxin products by improving lyophilization process Facility: GMP approved by KFDA