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Product Overview
BIENOX 100 Units and BIENOX 200 Units are prescription botulinum toxin type A injectable medicines from BNC Korea (Korea BNC), Republic of Korea. This TEOSQUARE page compares the two single-vial strengths for professional product identification and purchasing review. Each presentation contains Clostridium botulinum toxin type A with human serum albumin and sodium chloride as excipients, supplied as a dried preparation in a vial. The principal difference is the labeled potency of 100 U or 200 U per vial. Importantly, the referenced Korean record identifies BIENOX 200 Units as a product registered for export; authorization in the destination country must be checked separately.
Key Features
- Two labeled vial strengths: Compare BIENOX 100 U and 200 U per vial. These values identify product-specific potency, not a recommended treatment dose.
- BNC Korea product identification: Korean drug records identify Korea BNC as the manufacturer/importer entry for both strengths; verify the actual product carton for market-specific details.
- Dried vial formulation: Both records describe a white to pale-yellow dried preparation in a clear glass vial, with one vial per box.
- Albumin and sodium chloride excipients: Human serum albumin and sodium chloride are listed for both strengths. Exact quantities should be checked against the relevant product label.
- Refrigerated unopened storage: Korean labeling specifies storage in a sealed container at 2–8°C; maintain the required cold chain during professional distribution.
Composition & Specifications
| Specification | Details |
|---|---|
| Product Category | Prescription botulinum toxin type A injectable medicine |
| Active Ingredient | Clostridium botulinum toxin type A |
| Excipients | Human serum albumin; sodium chloride |
| Dosage Form | Dried powder for reconstitution as an injectable solution |
| Manufacturer | BNC Korea Co., Ltd. (Korea BNC), identified as manufacturer/importer in Korean drug records |
| Country of Origin | Republic of Korea |
| Container / Package | Single vial; 1 vial per box in the referenced Korean registrations |
| Unopened Storage | Refrigerate at 2–8°C in a sealed container |
| Korean Registration Distinction | 100 U: BIENOX Inj. (202400591); 200 U: BIENOX Inj. 200 Unit (for export) (202402821) |
Exact commercial labelling, authorised indications and import requirements depend on the destination country. Always verify the supplied product's packaging and current official prescribing information.
How It Works
Botulinum toxin type A acts at the neuromuscular junction, where nerve signals normally trigger the release of acetylcholine to activate muscle contraction. By inhibiting acetylcholine release from motor nerve endings, the toxin temporarily reduces activity in the affected muscles. This is the established pharmacological mechanism of botulinum toxin type A, not evidence that different products or strengths produce identical clinical outcomes.
The referenced Korean information for BIENOX describes temporary improvement of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adults aged 19–65. This is a summary of the Korean records, not a statement of authorization in other countries. Product-specific potency units are not interchangeable with units of other botulinum toxin brands.
Available Variants
The two BIENOX presentations are primarily distinguished by the number of labelled units in each vial. Vial strength is not a treatment-dose recommendation.
| Variant | Potency per Vial | Packaging | Korean Registration Reference |
|---|---|---|---|
| BIENOX 100 Units | 100 U | 1 vial / box | BIENOX Inj.; product code 202400591 (approved March 21, 2024) |
| BIENOX 200 Units | 200 U | 1 vial / box | BIENOX Inj. 200 Unit (for export); product code 202402821 (approved November 28, 2024) |
Regulatory distinction: the referenced 200 U registration is expressly labeled "for export" in Korea. A Korean product registration or export designation does not by itself authorize marketing, importation, or use in a destination country. Confirm product-specific labeling and applicable market permissions.
Professional Product Selection Considerations
Professional purchasers should identify the intended BIENOX strength and verify the applicable authorization before comparing product presentations. The larger 200 U vial is a different labeled strength, not evidence of greater clinical effect or longer duration.
- Strength and pack verification: Match the selected 100 U or 200 U label to the original vial and carton. The referenced records list one vial per box for both strengths.
- Registration and export status: BIENOX 200 U is recorded as an export presentation in Korea. Verify legal market access, prescribing information, and any import requirements in the destination country.
- Composition and traceability: Check the active ingredient, listed excipients, batch number, expiry date, and packaging integrity against the actual supplied product.
- Cold-chain planning: Both reference records specify unopened refrigerated storage at 2–8°C. Confirm the required conditions before procurement, shipment, and storage.
Storage & Handling
Store unopened BIENOX vials refrigerated at 2–8°C (36–46°F) in a sealed container, as specified in the referenced Korean product information. Maintain the required temperature conditions during storage and distribution. Do not use products with damaged packaging or an expired shelf life.
BIENOX is a prescription medicine for use only by appropriately qualified healthcare professionals. Consult the product-specific package insert for preparation, administration, post-reconstitution handling, contraindications and disposal. Botulinum toxin effects may spread beyond the injection site and cause serious adverse reactions, including swallowing or breathing difficulties.
Frequently Asked Questions
What is the difference between BIENOX 100 Units and BIENOX 200 Units?
BIENOX 100 U and 200 U differ in labeled potency per vial and their Korean registration records. Both are listed as single-vial dried botulinum toxin type A medicines with human serum albumin and sodium chloride. The 200 U record is specifically designated for export.
What are the ingredients in BIENOX?
The active ingredient is Clostridium botulinum toxin type A. The Korean product records list human serum albumin and sodium chloride as excipients. The excipient quantities should be checked against the exact product-specific label if required.
How should unopened BIENOX vials be stored?
The referenced Korean product information specifies refrigerated storage at 2–8°C in a sealed container. Any handling after reconstitution must follow the current professional prescribing information for the specific presentation.
Are BIENOX units interchangeable with other botulinum toxin brands?
No. Botulinum toxin potency units are product-specific and must not be directly converted between brands. Healthcare professionals must follow the appropriate prescribing information for the exact product being administered.
Does Korean registration mean BIENOX is approved in every country?
No. The Korean record for BIENOX 200 U is marked for export, but that does not confer authorization in another country. Professional purchasers must verify destination-market registration, import eligibility, labeling and distribution requirements.
Product Information Sources
- Korea Pharmaceutical Information Center — BIENOX Injection, 100 U (MFDS-sourced registration and prescribing information)
- Korea Pharmaceutical Information Center — BIENOX Injection, 200 U, for export (MFDS-sourced registration and prescribing information)
- Dongkook Pharmaceutical — BIENOX Injection product information
Regulatory references are Korean product records; they do not certify market authorization outside Korea. The latest original carton and approved prescribing information for the supplied SKU take precedence.