What Is Botox Made Of? A Full Ingredient Breakdown
What is in Botox?. A guide for patients
Summary
Botox contains three things:
A purified form of botulinum toxin type A
A single 100-unit vial holds 100 units of Clostridium botulinum type A neurotoxin complex,Human albumin 0.5mg
Sodium chloride 0.9mg
Botox is one of an increasing number of botulinum toxin type A products licensed in the UK for aesthetic use. Botox, Azzalure and Bocouture are currently the most common in use. They all contain the same class of active ingredient but different stabilising ingredients — Azzalure contains lactose, Bocouture contains sucrose. All three contain human albumin, which is derived from human blood plasma. Hence none of them could be regarded as vegan.
The active ingredient
The active ingredient in all three products is botulinum toxin type A, a protein produced by the bacterium Clostridium botulinum.
It is the same protein responsible for botulism, a serious form of food poisoning. That fact does a lot of work in the anxious corners of the internet, so it is worth stating precisely what the difference is. Botulism results from a large, uncontrolled dose of toxin absorbed systemically. A cosmetic treatment involves a purified, licensed preparation, measured in units, injected in minute quantities into a specific muscle. The quantity of clostridial protein in a 100-unit vial of Botox is roughly 5 nanograms — five billionths of a gram. We examine the safety issue of is Botox safe and the dangers of fake Botox.
The toxin is manufactured by bacterial fermentation under sterile laboratory conditions, then purified, freeze-dried or vacuum-dried, and tested against pharmacopoeial standards before release. It is not harvested from contaminated food, and it is not derived from snake venom, despite a persistent myth to that effect.
What else is in the vial
The active ingredient is present in vanishingly small amounts, which creates a practical problem: a few nanograms of protein will simply stick to the inside of a glass vial and disappear. Everything else in the formulation exists to stop that happening and to keep the protein stable until it is reconstituted.
Human albumin is a protein found in blood plasma, and it acts as a carrier and stabiliser. It coats the interior surfaces of the vial and the syringe so that the active protein stays in solution rather than adsorbing onto glass and plastic. All three UK products contain it.
Sodium chloride — ordinary salt — is present in Botox as a bulking agent and to keep the preparation at a pH compatible with human tissue.
Lactose monohydrate performs the equivalent bulking role in Azzalure.
Sucrose performs it in Bocouture, where it also acts as a cryoprotectant during freeze-drying.
Those three UK products compared
Complexing proteins, and why Bocouture is different
Botox and Azzalure both contain the neurotoxin bound up with accessory bacterial proteins i.e haemagglutinins and other non-toxic components that occur naturally alongside the toxin. Bocouture contains the 150 kD neurotoxin on its own, with those accessory proteins removed during manufacture.
The clinical significance is hotly debated, but the theoretical argument runs like this: accessory bacterial proteins represent additional foreign material presented to the immune system, and over repeated treatments some patients develop neutralising antibodies that make the treatment progressively less effective. Formulations free of complexing proteins contain substantially less bacterial protein overall, and incobotulinumtoxinA has shown low immunogenicity across more than a decade of clinical use.
If you have had treatment before and found it stopped working as well as it once did, formulation is one of several possible explanations worth raising with your prescriber — alongside dosing, injection technique, and the interval between treatments. We look at those issues in can Botox stop working.
Why you cannot compare prices per unit
This might be practically the useful thing on this page.
The units used by each product are not interchangeable. A Speywood unit of Azzalure is not equivalent to an Allergan unit of Botox, and neither is equivalent to a Merz unit of Bocouture. Each manufacturer defines its units by its own potency assay, and the summaries of product characteristics for these products state explicitly that doses are not convertible between preparations.
The practical consequence is that "£X per unit" tells you almost nothing unless you also know which product is being used. A clinic quoting a lower per-unit price may simply be using a product whose units are numerically smaller. You may need more of them for the same effect. Compare the total cost of treating an area, not the unit price, and ask which product is being used and why.
The questions people actually ask
Is it vegan?
No. All three products licensed in the UK contain human albumin, which is derived from donated human blood plasma. There is currently no vegan or plant-derived botulinum toxin available in the UK.
This matters beyond veganism. It is relevant to anyone who declines blood products on religious grounds, and to anyone who simply wants to know what they are consenting to. It is a reasonable question to ask at consultation, and any prescriber should be able to answer it without hesitation.
Is the human albumin safe?
Albumin used in medicines is prepared from screened donor plasma and subjected to manufacturing steps designed to inactivate or remove viruses. The European Medicines Agency's position is that the risk of transmitting infective agents cannot be entirely excluded when plasma-derived products are used, and it has encouraged the development of substitutes. In practical terms the residual risk is regarded as extremely low, and no cases of transmission via botulinum toxin products have been reported. But the honest answer is "extremely low," not "zero," and you are entitled to that distinction.
Does it contain anything from animals?
The toxin itself is produced by bacterial fermentation, not taken from any animal. There is no pig-derived, cow-derived or other animal-derived ingredient in the finished formulations of the three products discussed here. The human albumin is, as the name says, human.
Manufacturing processes differ between companies and some historical production methods used animal-derived materials in growth media. If this is material to your decision, ask your prescriber for the current summary of product characteristics for the specific product they intend to use.
I'm lactose intolerant. Does that matter?
Azzalure contains lactose monohydrate, and reactions in lactose-sensitive patients have been noted as a possibility. Dietary lactose intolerance is a digestive condition and is not the same thing as hypersensitivity to injected lactose, so for most people this is unlikely to be an issue. However, if you have a diagnosed milk protein allergy, as distinct from lactose intolerance, this is something to raise before treatment, and an alternative product may be more appropriate. Botox and Bocouture do not contain lactose.
Is it a poison?
Botulinum toxin is one of the most potent biological toxins known, and in that narrow technical sense the answer is yes. The distinction that matters is dose. A great many licensed medicines are toxic at the wrong dose; the definition of a medicine is largely a question of quantity and control. What makes a licensed preparation different from the toxin as it occurs in nature is purification, standardisation, unit-based dosing, prescription-only status and regulatory oversight. For more reassurance read Is Botox safe?
Is it approved in the UK?
Botox, Azzalure and Bocouture are all licensed by the MHRA and all are prescription-only medicines. That means each treatment must be prescribed for a named individual by an appropriately qualified prescriber i.e. a doctor, dentist, or independent nurse or pharmacist prescriber, following a face-to-face assessment of that person's suitability.
Azzalure is licensed for moderate to severe glabellar lines and lateral canthal lines in adults under 65. Bocouture is licensed for glabellar frown lines, lateral periorbital lines and horizontal forehead lines in adults under 65. Use outside a product's licensed indications is possible but is a matter for the prescriber's clinical judgement and should be discussed with you.
When these products should not be used
All three share broadly similar contraindications. They should not be used where there is known hypersensitivity to botulinum toxin type A or to any of the excipients listed above; where there is infection or inflammation at the proposed injection site; or in people with generalised disorders of muscle activity such as myasthenia gravis, Lambert–Eaton myasthenic syndrome or amyotrophic lateral sclerosis. They are not recommended during pregnancy or breastfeeding. Caution applies to people with bleeding disorders or taking anticoagulants.
This is not a complete list. A proper consultation covers your full medical history, current medication and previous treatments.
What to ask at a consultation
Which product do you intend to use, and why that one?
Who is prescribing it, and what is their registration number?
What is the total cost for the area being treated?
What are the contraindications relevant to my history?
A prescriber who cannot answer the first three without checking is not the right prescriber.
Sources
Nigam PK, Nigam A. Botulinum toxin. Indian Journal of Dermatology 2010;55(1):8–14. PMC2856357.
Frevert J. Content of botulinum neurotoxin in Botox/Vistabel, Dysport/Azzalure and Xeomin/Bocouture. Drugs in R&D 2010;10(2):67–73.
Azzalure 125 Speywood units, powder for solution for injection — Summary of Product Characteristics, electronic Medicines Compendium.
Bocouture 50 units / 100 units, powder for solution for injection — Summary of Product Characteristics, electronic Medicines Compendium.
European Medicines Agency, Note for Guidance on Plasma-Derived Medicinal Products (CPMP/BWP/328/99).
Complexing protein-free botulinum neurotoxin A formulations: implications of excipients for immunogenicity. PMC10892905.
This article is general information about a class of licensed medicines and is not medical advice, nor an offer or recommendation of treatment. Botulinum toxin products are prescription-only medicines. Any decision about treatment should follow an individual assessment by a qualified prescriber.
About the author
Dr Peter Forrester is Medical Director of The Cosmetic Doctors Company in Esher, Surrey.
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