Range — Oral care
Toothpaste and mouthwash manufacturing in Tunisia
Toothpaste manufacturing: toothpastes with or without fluoride, natural or in powder form, mouthwashes and mouth sprays for fresh breath. All the ranges are manufactured on our site in Tunisia, with our own equipment.
The range
Fluoride, format, claims: three choices to make first.
An oral care range starts with a question that brands, pharmacies and distributors ask very early: with or without fluoride? This choice shapes the formula, the label and the target audience, because a fluoride toothpaste is subject to a maximum concentration and to mandatory warnings, notably for young children. Then comes the format: classic, natural or powder toothpaste for daily brushing, mouthwash to complete the routine, spray to freshen the breath during the day.
Oppenheimer Lab manufactures, in contract manufacturing and private label, toothpastes with and without fluoride, natural toothpastes and powder toothpastes, mouthwashes and mouth sprays for fresh breath. Production takes place on our site in Tunisia, with our own equipment, in line with cosmetic Good Manufacturing Practice (ISO 22716); small batches are negotiable, from 100 to 200 units.
The boundary with medicinal products is part of the specification. A product for the teeth and the mouth remains a cosmetic as long as its main function is to clean, perfume, protect or keep in good condition; presented as treating or preventing a disease of the oral cavity, it falls outside this framework. The product name, its claims and its directions for use are therefore decided from the brief, together with the countries of sale, before designing the tube or the carton.
Products manufactured
What we make in oral care.
The standard products of the range, in small batches negotiable from 100 to 200 units.
Toothpastes
With or without fluoride
Natural toothpastes
Powder toothpastes
Mouthwashes
Mouth sprays
For fresh breath
Expertise
Our toothpaste and oral care manufacturing expertise
Toothpastes, mouthwashes and breath sprays are cosmetics, but their ingredients, their warnings and their claims are closely regulated. Here are the benchmarks to set before fixing a formula, each backed by an official text or a European reference document.
Teeth and mouth, within the scope of cosmetics
Regulation (EC) No 1223/2009 includes among cosmetic products the substances and mixtures placed in contact with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours. Toothpastes, mouthwashes and breath sprays are therefore designed around these functions.
Regulation (EC) No 1223/2009, Article 2(1)(a), consolidated version of 18 May 2026 (new tab)
Fluoride: 0.15% maximum, calculated as F
Annex III authorises twenty fluorine compounds in oral products, including sodium fluoride, sodium monofluorophosphate, stannous fluoride and several amine hydrofluorides. For each one, the maximum concentration is 0.15% calculated as F, and this ceiling remains the same when several fluorine compounds are combined. The label names the compound used, for example “Contains sodium fluoride”.
Fluoride toothpaste: the warning for children
A toothpaste with a fluorine concentration of 0.1 to 0.15% calculated as F must carry the warning: “Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.” The only exception: labelling that contra-indicates it for children, for example “for adult use only”. The target audience is therefore set before the carton.
Whitening: hydrogen peroxide capped
In oral products, including mouthwashes, toothpastes and whitening products, hydrogen peroxide present or released is limited to 0.1%. Above that, up to 6%, only tooth whitening or bleaching products are allowed: sold only to dental practitioners, with first use by them or under their direct supervision for each cycle, and not to be used under 18 years of age. A range intended for direct sale therefore stays at 0.1% at most.
Fresh breath, whiteness: claims to substantiate
Regulation (EU) No 655/2013 subjects every cosmetic claim to six common criteria: legal compliance, truthfulness, evidential support, honesty, fairness and informed decision-making. A statement such as “fresh breath” or “whiter teeth” is no exception: the claimed effects cannot go beyond those demonstrated by the available supporting evidence. The intended claims are therefore set from the brief, together with the evidence that will substantiate them.
Regulation (EU) No 655/2013, Annex, common criterion 4 “Honesty”, point 1 (new tab)
Cosmetic or medicinal product: the presentation decides
According to the European manual on the scope of the cosmetics regulation, a mouthwash or a dental gel can remain a cosmetic with a secondary “antimicrobial” claim, if its main function is cosmetic. On the other hand, a product presented or intended for the treatment or prevention of infections, inflammation or other diseases of the oral cavity is not a cosmetic. The qualification is a matter for the national competent authorities, case by case.
Sources consulted on 31 October 2026.
Our support
Made in Tunisia, from the formula to the batch.
Manufacturing on our site
All the ranges are manufactured on our site in Tunisia, with our own equipment, in line with cosmetic Good Manufacturing Practice (ISO 22716 / GMP).
Regulatory file
Preparation of product information files (PIF) and CPNP notifications.
Batches and lead times
Small batches possible: from 200 units, or even 100 depending on the project, subject to assessment. Allow 45 to 90 days for private label, 3 to 6 months for custom private label and 6 to 12 months for custom formulation.
FAQ
Frequently asked questions
Toothpaste with or without fluoride: which to choose for my brand?
Both are possible: we manufacture toothpastes with and without fluoride. A fluoride toothpaste complies with the 0.15% limit calculated as F in Annex III of Regulation (EC) No 1223/2009 and names the compound on the label; between 0.1 and 0.15%, it also carries the warning intended for children aged 6 and under, unless it is contra-indicated for them. A fluoride-free version cannot denigrate ingredients legally used (Regulation (EU) No 655/2013).
Can a toothpaste promise whiter teeth?
Yes, if the announced effect is demonstrated and the formula complies with Annex III. In an oral product, hydrogen peroxide present or released is limited to 0.1%; between 0.1% and 6%, the whitening product is reserved for dental practitioners and not to be used under 18 years of age. And, under Regulation (EU) No 655/2013, the claimed effects cannot go beyond those demonstrated by the available supporting evidence.
Does a mouthwash claiming an antimicrobial action remain a cosmetic?
Yes, if this claim remains secondary and its main function is cosmetic: cleaning, perfuming, protecting or keeping the teeth and the mouth in good condition. This is the reading of the European manual on the scope of the cosmetics regulation. Presented as treating or preventing infections, inflammation or other diseases of the oral cavity, it is no longer a cosmetic; the qualification is a matter for the national authorities, case by case.
Can a breath spray be sold as a cosmetic?
Yes, if it has a cosmetic function, such as freshening the breath, and is not intended to be swallowed. Among the criteria of the European manual on the scope of the cosmetics regulation: the label or the directions for use ask to spit out or rinse off the excess, and the product is not designed to dissolve in saliva. A spray intended to be ingested is not a cosmetic. Mouth sprays for fresh breath are part of our range.
From how many units can a toothpaste in a tube or in powder be launched?
At Oppenheimer Lab, small batches are possible from 200 units, or even 100 depending on the project, subject to assessment, for a toothpaste in a tube as well as in powder. Allow 45 to 90 days for private label, 3 to 6 months for custom private label and 6 to 12 months for custom formulation. We recommend testing the formula-container pairing before launching the full order, and starting with one or two well-positioned products before expanding the range.
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A toothpaste or a mouthwash to launch?
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