Each vial contains:
Active ingredient: Clostridium botulinum toxin type A (MFDS-approved specifications) 100 units
Stabilizer: Human serum albumin (MFDS-approved specifications, Specification and Test method of Biologics) 0.5 mg
Tonic adjuster: Sodium chloride (Korean Pharmacopoeia) 0.9 mg

White or pale-yellow vacuum-dried powder in a colorless transparent vial; a clear and colorless solution when dissolved in 0.9% sodium chloride for injection.

Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator muscle and/or procerus muscle activity in adults aged between 19 to 65 years.

Store at Sealed containers, refrigeration (2~8 C), 36 months form the date of manufacture.

Neurocalm 100 Units (Clostridium botulinum Toxin Type A) is reconstituted only with preservative-free 0.9% sterile saline to 100 U/2.5 mL (4 U/0.1 mL). Using a 30-gauge needle, administer to five sites at glabellar lines, i.e. two sites at the respective corrugator muscle and one site at the procerus muscle at 0.1 mL each, 20 U in total.

A. Middle of corrugator supercilii muscle
B. Medial corrugator supercilia muscle
C. Procerus muscle

To reduce complications of drooping (ptosis) eyelids, avoid injection near the levator palpebrae superioris, for patients particularly with large corrugator muscles. When administering injection in the medial corrugator muscle and in the midpoint between each eyebrow, it must be done at a place at least 1 cm apart from the supraorbital ridge.

Be aware not to inject this drug into the blood vessel. To prevent effusion from the area below the orbital ridge, place a thumb or an index finger firmly on the area below the orbital ridge prior to injection.
During the injection, the needle should be pointes upward toward the center, and the injection dose must be accurate.
The corrugator muscle and the orbicularis oculi muscle move the middle of the forehead to create glabellar facial lines. The procerus and depressor supercilii muscles pull the forehead down. These muscles produce frowns or glabellar lines. Since the location, size, and use of muscles vary each other, the effective dose is determined by entire observation of the patient’s ability to actuate the injected superficial muscles.

Safety and efficacy of this drug for glabellar lines were assessed for 16 weeks after the single dose.

1. Warnings
Since the active ingredient of this drug is Clostridium botulinum type A produced by Clostridium botulinum bacteria, fully understand the precautions for use and strictly follow the dosage and administration. The Attending physician who administers the drug must have a deep understanding of the related nerve roots and anatomical structures around the eye, anatomical changes due to previous surgery, and standard electromyograph.
The recommended dosage and frequency of administration should not be exceeded.
1) Long-distance Spread of Toxin Effect
Botulinum toxin can spread from the injection site to other sites, causing botulism. Symptoms such as sudden muscle weakness, loss of energy, double vision, blurred vision and drooping eyelids can occur.
2) Hypersensitivity Reactions
Serious and/or immediate hypersensitivity reactions have been rarely reported for other botulinum toxin preparations. These reactions include anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea. One case of anaphylaxis has been reported in which lidocaine was used as the diluent, but it is not reliably determined to find a causative substance. If such a reaction occurs, further injection should be discontinued, and appropriate medical therapy should be instituted immediately.
3) Individuals with peripheral motor neuropathic diseases (e.g. amyotrophic lateral sclerosis, or motor neuropathy) or neuromuscular junctional disorders (e.g. myasthenia gravis or Lambert-Eaton syndrome) may be at increased risk of clinically significant systemic effects including severe dysphagia and respiratory compromise from typical doses of botulinum toxin preparations. Published medical literatures on other botulinum toxin preparations have reported rare cases of administration of botulinum toxin to patients with known or unrecognized neuromuscular disorders where the patients have shown extreme sensitivity to the systemic effects of typical clinical doses. In some of these cases, dysphagia has lasted several months and required placement of a gastric feeding tube.
4) With the administration of other botulinum toxin preparations, adverse cardiovascular events including arrhythmias and myocardial infarction have rarely been reported, and some have been fatal. Some of them had pre-existing risk factors, including cardiovascular disease.
5) Not Interchangeable
Because different botulinum toxin preparations may have different toxin content, Unit in one product cannot be converted into unit in another product.

2. Do not administer to the following patients:
1) Individuals with known hypersensitivity to any ingredient in this drug.
2) Patients with systemic neuromuscular junction disorder (myasthenia gravis, Lambert-Eaton syndrome, or amyotrophic lateral sclerosis).
3) Pregnant or possibly pregnant women and lactating women.
4) Patients with presence of infection at the proposed injection site(s).

3. Administer to the following patients with extra care:
1) Receiving any muscle relaxants such as tubocurarine chloride, dantrolene sodium – the muscle relaxation effect may be enhanced.
2) Receiving any medications that inhibit the neuromuscular function, including, but not limited to, spectinomycin hydrochloride, aminoglycoside antibiotics (such as gentamicin sulfate and neomycin sulfate), polypeptide antibiotics (such as polymyxin B sulfate), tetracycline antibiotics, lincomycin antibiotics (such as lincosamides), muscle relaxants (such as baclofen), anticholinergics (such as butyl scopolamine bromide and trihexyphenidyl hydrochloride), benzodiazepines and their analogues (such as diazepam and etizolam), and benzamides (such as tiapride hydrochloride and sulpiride) – the muscle relaxation effect may be enhanced.