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Atopis eczema cream gets FDA OTC Status in USA

MD Magazine runs Atopis FDA story – “Novel, Natural Eczema Cream Gets FDA OTC registration”

December 1, 2017

Leading USA MD Magazine has picked up on the Atopis Press Release on the success in achieving US FDA OTC (Over-The-Counter) status for Atopis cream – Click the press release link to see the MD story:

A press release     regarding the approval was made available.

Our press release reads:


A cream made from natural New Zealand ingredients clinically proven to treat eczema is set to help millions of American sufferers, after achieving OTC (over the counter) status for the US market.

Atopis’ Eczema Therapy Cream has been seven years in the making and will soon be sold online to American customers after meeting OTC regulatory requirements set by the US Food and Drug Administration.

This US OTC Status is believed to be a first for a New Zealand-made pharmaceutical product, and opens up a multi-billion dollar market.

Clinical trials in the US and New Zealand showed the cream – so natural you can eat it – successfully treats eczema without containing any parabens, solvents or steroids.

The cream is the culmination of knowledge amassed from more than 30 years of research and pharmaceutical development by Auckland scientist Dr Iona Weir, CEO of Bionona.

“It’s taken a long time to get here, but it is just so rewarding to know I have created a natural

product that is scientifically proven to help people, and now we are going into America – it can

help even more. The OTC Status is a coup for our company as well as for New Zealand”.

She’s used mainly native ingredients from her surroundings in the Waitakere forests for the eczema cream and a patented method, similar to fermentation, to extract nutrients from ingredients including bee pollen, coconut, honeydew and bacteria grown in New Zealand forests.

“I wanted to create something completely natural, but that could still get proven results from robust clinical tests on humans. We’ve gone through the world’s most rigorous clinical testing to prove that this is a natural product which actually works.”

Dr Weir has worked to harness the natural cell repairing processes of plants to treat topical skin conditions.

“By opening up to one of the biggest markets in the world, a New Zealand-made product can now help people treat their eczema with a clinically-proven, natural product. Eczema treatment is a multi-billion dollar market in the US and we have a world-leading product.”

Not only did the company have to meet the FDA’s strict criteria for the Over The Counter criteria, but it also had to prove its accredited status to Amazon, which it will sell through.

Eczema Therapy Cream will replace the Dry Itchy Skin Cream in the brand’s line of three products.

The new cream has a slightly different recipe to the older version which has been sold on the Atopis website along with the brand’s Acne Prone Skin Care and Anti-Aging Cream.

The new Eczema Therapy Cream will be available online in early February.




Our Featured Products

Dry Itchy Skin Cream


Eczema prone skin-types Clinically shown to rapidly relieve dry itchy, irritated skin and reduce redness. Within two weeks of use, this potent all-natural therapy promotes cell renewal, hydrates and restores the skin leaving your skin feeling soft and no longer dry and itchy. Atopis works in synergy with your immune system so you stop reacting to environmental triggers.

Acne Prone Skin Cream


Teenage and adult acne Gently exfoliates and calms acne-prone skin. Helps dissolve and regulate skin oils and sebum, to support a clearer, softer and smoother skin. Atopis has been scientifically shown to increase the number of good bacteria, as well as inhibit bad bacteria levels on your skin, resulting in a healthy natural balance.    

Anti-Aging Cream


Intense hydration for dry skin Scientifically formulated to intensely hydrate and rejuvenate skin that has lived. Atopis promotes cell renewal and restores collagen production to smooth lines and wrinkles. Clinically shown to reduce redness and even skin tone.  Atopis leaves skin feeling soft and revitalized with a youthful glow            

Radiant Balance Cream


Normal and combination skin Radiant Balance promotes clear, calm and hormonally balanced skin. Clinically shown to reduce redness, even skin tone and revitalise dull skin while reducing acne breakouts. Scientifically formulated for normal to combination hormonal skin types.

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