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preservatives allowed for dental products?
Any preservatives allowed for dental products ( dental mouth wash or gum gel)?
I could think of Sodium benzoate but wondering any effective ones to boost preservative efficacy? How about Potassium sorbate?
Thank you.
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16 Replies
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if you want a preservative that’s universally approved, safe to use, doesn’t have a noticeable taste, and is effective over a broad pH range, then sodium methyl paraben is your best bet
propylene glycol works well as a preservative booster, particularly if it’s included at 5-10%
sodium benzoate is only effective below pH 5, and while you might get away with a pH that low in a mouthwash (since it only has transient contact with the teeth), a toothpaste or any other product intended for prolonged/intimate contact would very likely erode the teeth if it were that acidic
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@Bill_Toge Thank you for your comment. Yes I have been using sodium benzoate but doesn’t seem like it’s working I use it for a gum gel and doesn’t seem like it’s working overall ( I don’t think I can formulate pH below 5…) Any suggestions? I heard ehtylhexylglcyerin is also effective but not sure…
I would like to use parabens but the overall formula is paraben free.. any suggestions?Thanks again
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in my experience ethylhexylglycerin works well in combination with small amounts of other preservatives, as does caprylyl glycol
1,2-hexanediol (Hydrolite 6 from Symrise, or SymDiol 68 as a blend with caprylyl glycol) is supposed to be effective as well, but I’ve not used it myself
the only possible points of contention that immediately spring to mind are how they taste (I’ve not tried using them in oral care, so I can’t comment on this), and whether or not there’s enough toxicity data to support their use in oral care; if memory serves, I believe SymDiol 68 has been used in mouthwashes, but I can’t comment on the others
also, they are expensive compared to sodium methyl paraben
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The most common one is benzoic acid/sodium benzoate with corn-derived alcohol at about 20% in the formulation.I would suggest you go to the supermarket and read the labels of competitive products. Find one or two that have similar attributes to the product you are formulating, buy a bottle, take them home and measure the pH. That will give you an idea of what preservatives your competitors are using and the pH of their formulations. -
I’m working on a mouthwash too, i don’t mind parabens so much but its not easy to buy sodium methyl paraben online…could a paraben blend be possible? such as Germaben II (Propylene Glycol (and) Diazolidinyl Urea (and) Methylparaben (and) Propylparaben) or Paraben DU (Propylparaben, methylparaben, diazolidinyl urea, propylene glycol)?
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Paraben DU is a very effective preservative.
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I suppose is safe for oral products??
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IF your mouthwash has 13% or more ethanol, (SDA 38C if memory serves is the one with thymol and spearmint suitable for dentrifices), then you don’t need to worry about a preservative all. Likewise, if your “gum gel” has lidocaine HCl and oxiquinoline sulfate or pramoxine HCl as the old-school ones had, no preservative needed either.
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As there`s been a growing awareness of parabens` cancerogenic abilities and they`ve been forbidden in many countries, I would advise to look at other options nowadays.
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@biomate Did you read the CIR report (https://www.cir-safety.org/supplementaldoc/safety-assessment-parabens-used-cosmetics) or the Scientific Committee of the EU opinion (ec.europa.eu
https://ec.europa.eu › docsPDFSCCS/1514/13 - Scientific Committee on Consumer Safety - European Commission) on parabens?
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@biomate
That is total garbage. Where are parabens forbidden?
I advise you not repeat chemophobic propaganda any day. -
I see one of my fav’s in a number of oral care products… O-Cymen-5-Ol, a synthetic derivative of thymol. I think it needs some friends…but a decent start.
@biomate did auto correct change your comment from ‘ignorance’ to ‘awareness’?
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If mouth wash contains Chlorhexidine, does it require extra preservative?
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@amitvedakar
Prob so - you’ll find alcohol in the best known application - Peridex. This is a drug product and some might consider their manuf to be sufficiently under control and application sufficiently controlled that nominal preservation is not needed.
It is really not a consumer product as casual use will enrage many due to tooth staining that is effectively permanent. -
I do confess to have succumbed to that ‘propaganda’. Thank you for clarifying the matter for the others.Anyway, due to anti-paraben attitude among consumers, we always avoid it in our formulations.These are the maximum allowed levels in cosmetics:ethylparaben: 0.4%methylparaben: 0.4%bytylparaben and propylparaben: 0.19%.Overall max. content cannot exceed 0.8% in formulations.There is however a range of forbidden parabens that are:izobutylparaben, izopropylparaben, pentylparaben, phenylparaben, benzylparaben.Thank you and my apologies again for introducing unverified info.
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Those “forbidden” parabens are molecules that are not listed in Directives. These were not offered for use and no safety data was generated to justify their use.
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