Is Trifectiv Plus safe?

Trifectiv Plus goes onto cuts, burns and chronic wounds, into sore throats and onto nappy rash, and in the Air version it's breathed in through a nebuliser. So it's fair to want to know exactly what's in the bottle and how safe it is. This page covers what hypochlorous acid is, what being a medical device means and what our package inserts say about safety (word for word, where it matters). The sources are listed at the bottom.

What hypochlorous acid is

Hypochlorous acid (HOCl) is a small molecule made of hydrogen, oxygen and chlorine, and your body already makes it. White blood cells called neutrophils use an enzyme, myeloperoxidase, to turn hydrogen peroxide and ordinary chloride into hypochlorous acid, and they use it to fight infection.

Trifectiv Plus is that same molecule: premium-grade hypochlorous acid, made with medical-grade water, and that's the whole formula. It's a clear, colourless liquid. (The chemistry has been known for nearly two hundred years. Keeping hypochlorous acid stable in a bottle is the hard part, and that's what Thoclor Labs' own manufacturing method is for.)

Where it comes from (and why it isn't bleach)

Hypochlorous acid was first described in 1834 by Antoine-Jérôme Balard, the French chemist who discovered bromine. He was working out how bleach works, and he made hypochlorous acid and named it along the way.

Bleach (sodium hypochlorite) is a related but different substance, and most of the well-known chlorine stories belong to it. Dakin's solution, used to irrigate soldiers' wounds in the First World War, was a dilute bleach. And drinking water has been treated with chlorine since the early 1900s.

The two are connected. When chlorine or bleach goes into water, some of it becomes hypochlorous acid, and that's the form doing most of the disinfecting. But they're different substances that behave differently (Japan's health ministry makes a point of saying so), so we keep them apart and don't claim bleach's history as ours. Hypochlorous acid's own story came much later, once researchers showed that neutrophils make it.

What "Class C medical device" means

Trifectiv Plus is a Class C medical device in South Africa. Its insert describes Trifectiv Plus Wound & Burn Care as a "wound irrigation solution, antimicrobial", suitable for use on open wounds and for "any condition where the skin's integrity is compromised" (in plain English, wherever the skin is broken or damaged).

South Africa's medical device rules sort devices into four classes, A to D, by what they're for, how invasive they are, how long they're used and the risk involved. A plaster or a gauze pad is Class A. Dressings made for chronic ulcers and serious burns are Class C, because of the kind of wound they go on.

Thoclor Labs makes Trifectiv Plus in Stellenbosch under licence 733MD from SAHPRA, the South African Health Products Regulatory Authority. No medical device may be made or sold in South Africa without a licence like this, and a company needs a working quality system to get one. The facility is also ISO 13485:2016 and GMP certified. ISO 13485 is the international standard for quality systems in the medical device industry, and GMP stands for good manufacturing practice.

Who can use it

The Wound & Burn Care insert says it's "safe to use during pregnancy and lactation, as well as on children, babies and animals". That covers most households (the family dog included).

It's safe if swallowed, too. The insert has you spray it straight into a sore throat and into a baby's mouth for oral thrush. And under "known symptoms of overdose", the insert's answer is "none known".

When to hold back

The insert names two situations to keep in mind. Don't use it on the face for long periods. And expect it to work less well alongside cortisone or an anti-inflammatory gel.

If a wound or skin condition isn't getting better within two to four days, please see your doctor, nurse or pharmacist. Some chronic wounds also have dead tissue that a nurse or doctor needs to remove before the first application, so it's worth having a stubborn wound looked at before you start. And don't use a bottle that's past its expiry date.

Does it sting?

Most people feel nothing at all. Some feel a slight sting at first, either from the difference in temperature between the spray and the skin or from another product still left on the skin or in the wound, and it usually passes within a minute. (The insert puts it as "slight stinging may occur for the first day of use".)

So rinse out any other antiseptic first. Before the first dressing on a cut or graze, the insert's method is a sponge, warm water and a little bubble bath, rinsed off completely with clean water, then patted dry.

A few practical rules

Keep it away from other disinfectants. Don't mix it with saline, chlorhexidine, iodine or any other disinfectant, and don't use it with them or after them. Waterproof and silver dressings are out too. The insert's method is wet woven gauze held in place with a crepe bandage or breathable dressing, and the full steps are on our usage page.

The bottle is glass, so take care not to drop it and don't leave it within reach of babies and toddlers. Put the cap back on after use, which protects the nozzle and helps prevent breakage. Store it at room temperature out of direct sunlight, and use it within twelve months of opening.

Trifectiv Plus Air: a few extra rules

Trifectiv Plus Air Nebulising Solution is the same molecule, breathed in through a nebuliser, so it has its own insert.

The most important rule comes first. Don't use it at the same time as a cortisone or steroid inhaler. If you use one, talk to your doctor before you start, and please don't stop or change a prescribed inhaler on your own.

Children, and anyone with a diagnosed respiratory condition, should use it with their doctor's guidance. The Air insert says it's "safe for the entire family including during pregnancy and lactation and for babies and children", and it lists no known symptoms of overdose.

Use it undiluted, with nothing mixed in (and never with saline), in a modern nebuliser that makes a very fine mist. Adults use five millilitres a session. Children use half a millilitre for each year of age, up to five millilitres. How often depends on why you're using it, and the Air page sets that out. If things aren't improving within twenty-four to forty-eight hours, see your doctor.

A slight cough in the first few breaths can happen, and so can a dry throat or a sneeze afterwards. Some people bring up more phlegm than usual after two or three days. The insert puts that down to mucus that was already in the lungs coming up, but if you're worried, see your doctor.

Pour out only what you need for each session and never pour leftovers back into the bottle. Don't leave the solution standing in the nebuliser between sessions either (it's very sensitive to light). This bottle is glass too, and once it's open, use it within six months.

Where else hypochlorous acid is used

Hypochlorous acid in general (not only ours) is used in wound care, including for chronic wounds and ulcers. It's used to sanitise food-contact surfaces and equipment in restaurants, dairies and food factories, and some countries allow it in the water used to wash fresh produce. And wherever drinking water is treated with chlorine, hypochlorous acid forms in the water and does much of the work.

A few regulators name it in their rules for food and sanitising. In the United States, the Environmental Protection Agency exempts hypochlorous acid from needing a residue limit when it's used, up to a set strength, in sanitisers for food-contact surfaces in restaurants, dairies and food-processing plants (as long as the surface drains before food touches it). The US Department of Agriculture's organic rules allow hypochlorous acid made from electrolysed water (salt water run through an electric current) for disinfecting and sanitising equipment and surfaces on organic farms and in organic food handling. They also allow it in water that touches crops or food, as long as there's a rinse with drinking water afterwards. And in 2002, Japan's Ministry of Health, Labour and Welfare designated "hypochlorous acid water" as a food additive, for disinfecting food.

These are about hypochlorous acid as a substance, in food and sanitising. None of them is an approval of Trifectiv Plus, and none is about wound care. For Trifectiv Plus itself, the medical device rules above are the ones that apply.

If you're a nurse, doctor or pharmacist, the full package inserts are below, and we're happy to send the clinical papers on request. And if anything here doesn't answer your question, email or WhatsApp us. We'd rather you asked than guessed.

Download the package inserts:

1. Trifectiv Plus Wound & Burn Care 100 ml (EN)
2. Trifectiv Plus Air 50ml (EN)
3. Trifectiv Plus Wound & Burn Care 450ml (EN)