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Product Overview
INNOTOX is a ready-to-use liquid botulinum toxin type A injectable medicine developed and manufactured by Medytox Inc. in South Korea. Unlike conventional lyophilized botulinum toxin formulations, INNOTOX is supplied as a sterile aqueous solution that does not require reconstitution before administration. The product contains Clostridium botulinum toxin type A (Hall strain) at a concentration of 40 U/mL. INNOTOX is available in 50U and 100U presentations, containing 1.25 mL and 2.5 mL respectively. Its formulation uses L-methionine and polysorbate 20 rather than human serum albumin.
Key Features
- Ready-to-Use Liquid Formulation: INNOTOX is supplied as a pre-formulated, colorless injectable solution. Unlike freeze-dried botulinum toxin products, it does not require reconstitution before use.
- Two Vial Strengths: INNOTOX 50U contains 50 units in 1.25 mL, while INNOTOX 100U contains 100 units in 2.5 mL. Both presentations have the same labeled concentration of 40 U/mL.
- Human Serum Albumin-Free: INNOTOX uses L-methionine and polysorbate 20 as formulation components instead of human serum albumin. This distinguishes it from many conventional botulinum toxin products that contain albumin stabilizers.
- Botulinum Toxin Type A: The active ingredient is Clostridium botulinum toxin type A derived from the Hall strain. Its pharmacological action involves the temporary inhibition of acetylcholine release at cholinergic nerve terminals.
- Refrigerated Vial Presentation: INNOTOX is supplied in a clear glass vial and requires refrigerated storage at 2–8°C. The documented presentations contain one vial per box.
Composition & Specifications
| Specification | Details |
|---|---|
| Product Name | INNOTOX |
| Alternative Name | Innotox Injection |
| Korean Product Name | 이노톡스주 |
| Manufacturer | Medytox Inc. |
| Country of Origin | Republic of Korea |
| Product Category | Botulinum toxin type A prescription injectable medicine |
| Active Ingredient | Clostridium Botulinum Toxin Type A (Hall Strain) |
| Active Ingredient Concentration | 40 U/mL |
| Available Strengths | 50U and 100U |
| INNOTOX 50U Volume | 1.25 mL per vial |
| INNOTOX 100U Volume | 2.5 mL per vial |
| Formulation | Ready-to-use aqueous solution for injection |
| Appearance | Colorless, transparent liquid in a clear, colorless vial |
| Listed Excipients | L-Methionine, Polysorbate 20, Sodium Chloride, Water for Injection |
| Human Serum Albumin | Not included |
| Lidocaine | Not included |
| Reconstitution | Not required; supplied as a liquid formulation |
| Packaging | 1 vial per box |
| Storage Temperature | 2–8°C (36–46°F) |
| Storage Container | Hermetically sealed vial |
| ATC Classification | M03AX01 — Botulinum Toxin |
| Korean Regulatory History | Originally authorized as a prescription medicine; subject to a 2021 marketing authorization cancellation order and subsequent legal proceedings. Current authorization must be independently verified. |
INNOTOX 50U and 100U share the same 40 U/mL concentration and listed excipients. Their primary differences are total potency and solution volume per vial. The product has been subject to regulatory proceedings in South Korea. Historical registration information must not be interpreted as confirmation of unrestricted current authorization, distribution or legal availability.
How INNOTOX Works
Botulinum toxin type A acts on cholinergic nerve terminals by inhibiting the release of acetylcholine, a neurotransmitter responsible for transmitting signals between motor nerves and muscles.
Following its interaction with the presynaptic nerve terminal, the toxin's light chain cleaves SNAP-25, a protein involved in the SNARE complex required for neurotransmitter vesicle fusion. This process temporarily reduces neuromuscular transmission and the activity of affected muscles.
INNOTOX uses the same general botulinum toxin type A pharmacological mechanism as other products in this category. However, its liquid formulation differs from the freeze-dried powders commonly supplied by other manufacturers.
Because INNOTOX is supplied as a pre-formulated aqueous solution, the labeled concentration is established before the vial is opened. This eliminates the separate reconstitution step required for lyophilized formulations. It does not eliminate the need for appropriate handling, clinical precautions or professional administration.
Botulinum toxin potency units are specific to the manufacturer's biological activity assay. INNOTOX units must not be considered interchangeable with units from other botulinum toxin brands.
Available Variants
INNOTOX is available in 50U and 100U liquid formulations. Both strengths contain Clostridium botulinum toxin type A at 40 U/mL and use the same documented albumin-free excipient system. The larger presentation contains twice the total solution volume and labeled potency of INNOTOX 50U.
| Product | Strength | Concentration | Vial Volume | Packaging |
|---|---|---|---|---|
| INNOTOX 50U | 50 Units | 40 U/mL | 1.25 mL | 1 Vial / Box |
| INNOTOX 100U | 100 Units | 40 U/mL | 2.5 mL | 1 Vial / Box |
Both presentations are ready-to-use liquid botulinum toxin formulations. The difference in vial strength should not be interpreted as a difference in solution concentration. Product strengths describe total labeled biological potency, not recommended treatment doses.
Professional Product Selection Considerations
Professional buyers evaluating INNOTOX should distinguish its liquid formulation from conventional lyophilized botulinum toxin products. Vial strength, concentration, excipient composition, storage conditions and regulatory status are important considerations when reviewing the available presentations.
- Verify Vial Strength and Volume: INNOTOX 50U contains 1.25 mL, while INNOTOX 100U contains 2.5 mL. Both have a concentration of 40 U/mL. Confirm the selected strength on the original carton.
- Identify the Liquid Formulation: INNOTOX is supplied as a ready-to-use aqueous solution. It should not be confused with Medytox's other botulinum toxin products supplied as lyophilized powders.
- Review the Albumin-Free Composition: INNOTOX contains L-methionine and polysorbate 20 rather than human serum albumin. An albumin-free formulation does not guarantee the absence of hypersensitivity reactions or other adverse effects.
- Confirm Refrigerated Storage: Both documented strengths require storage at 2–8°C. Check the original packaging, batch information and expiration date before professional procurement.
- Verify Current Regulatory Authorization: INNOTOX was subject to a South Korean marketing authorization cancellation order in January 2021. Enforcement was subsequently stayed during legal proceedings. Manufacturer disclosures in 2026 continued to identify ongoing litigation. Current legal marketing status must be verified before procurement, distribution or clinical use.
Storage & Handling
Medytox specifies refrigerated storage at 2–8°C (36–46°F) in a hermetically sealed container. Maintain the labeled conditions during transportation, warehousing and professional handling.
INNOTOX is supplied as a sterile liquid formulation. It does not require reconstitution, but its ready-to-use presentation does not remove the need for appropriate aseptic handling and professional administration.
Shelf-life information has differed between historical regulatory publications and commercial listings. Follow the expiration date and current storage instructions on the original product carton. Do not use expired products or vials with compromised packaging.
Botulinum toxin products can cause adverse reactions, including injection-site discomfort, localized muscle weakness and hypersensitivity. Serious complications may occur when toxin effects spread beyond the intended area, potentially causing difficulty swallowing, speaking or breathing.
INNOTOX is a prescription injectable medicine intended for appropriately qualified healthcare professionals. Historical product registrations and manufacturer listings do not establish current legal availability. Verify the applicable regulatory status, authorized indications, contraindications and current prescribing information before use.
Frequently Asked Questions
What is the difference between INNOTOX 50U and INNOTOX 100U?
Both products contain botulinum toxin type A at 40 U/mL. INNOTOX 50U contains 50 units in 1.25 mL, while INNOTOX 100U contains 100 units in 2.5 mL. Both are supplied as ready-to-use liquid formulations in single-vial boxes.
Does INNOTOX require reconstitution?
No. INNOTOX is supplied as a pre-formulated liquid solution, unlike conventional lyophilized botulinum toxin products that require reconstitution before use. Product handling must still follow the current official prescribing information.
Does INNOTOX contain human serum albumin?
No. The registered ingredient composition lists L-methionine, polysorbate 20, sodium chloride and water for injection as excipients. Human serum albumin is not included in the documented formulation.
Who manufactures INNOTOX?
INNOTOX is developed and manufactured by Medytox Inc., a South Korean biopharmaceutical company specializing in botulinum toxin products and medical aesthetics.
Is INNOTOX the same as Meditoxin or Neuronox?
No. INNOTOX is Medytox's ready-to-use liquid botulinum toxin type A formulation. Meditoxin, also marketed internationally as Neuronox, is a separate product family supplied as a lyophilized powder. Their units must not be assumed interchangeable.
What is the regulatory status of INNOTOX in South Korea?
INNOTOX received Korean pharmaceutical authorization historically but was subject to a marketing authorization cancellation order in January 2021. The order's enforcement was subsequently stayed by the courts, and manufacturer disclosures in 2026 identified ongoing administrative litigation. Current authorization and legal availability require verification with the relevant regulatory authority.