BUTTER-C
Signature ingredients
Sodium fluoride toothpaste OEM/ODM manufacturing
Sodium Fluoride Toothpaste · Signature Ingredients · OEM/ODM
Sodium fluoride (INCI Sodium Fluoride, NaF) is a simple inorganic salt that supplies fluoride ions to toothpaste: dissolved in water, it splits straight away into sodium and fluoride ions. Among oral care ingredients, fluoride has a large body of dental evidence — a 2019 Cochrane review included 96 randomized trials of fluoride toothpaste — but precisely because it is a potent active, sodium fluoride is also tightly restricted: ASEAN Annex III allows it only in oral hygiene products, at no more than 0.15% calculated as fluorine, with all fluorine compounds added together and mandatory label wording. For brand owners, that dental evidence explains why the toothpaste contains fluoride, while the claim “helps prevent cavities” on the label is still used only when the regulatory affairs team confirms it in writing. Unlike the general toothpaste page (many lines, many actives), this page goes deep into what is specific to sodium fluoride: converting the salt to fluorine, choosing an abrasive that does not “lock up” fluoride, testing soluble fluoride rather than total fluoride only, copying the warnings exactly and handling a raw material that is toxic if swallowed. The product is positioned for adults; children’s toothpaste has its own page. Butter-C offers turnkey OEM/ODM manufacturing, from formulation and testing to a finished, labeled product with its notification dossier.
Formula base
Sodium fluoride dissolved in a silica toothpaste base
Sodium fluoride dissolves in the water phase of the paste; the rest of the formula — abrasive, humectants, structurants, foaming agents, flavor, preservative — is chosen so that fluoride stays in soluble form.
Sodium fluoride — reading the raw material correctly
PubChem (CID 5235): NaF, 41.99 g/mol, CAS 7681-49-4; water solubility about 4.0 g/100 mL at 15 °C and 4.3 g/100 mL at 25 °C, insoluble in alcohol. From atomic masses: 1 g NaF contains about 0.4525 g fluorine (18.998 / 41.988). Butter-C currently stocks sodium fluoride declared as INCI Sodium Fluoride; each lot’s certificate of analysis must state the NaF content so the conversion can be corrected. Do not confuse it with sodium monofluorophosphate (MFP, Annex III Ref 27 — fluorine sits inside the monofluorophosphate ion), stannous fluoride (Ref 35) or sodium fluorosilicate (Ref 40).
Abrasive: hydrated silica
In Hattab’s storage experiments (1989), adding sodium fluoride solution to aluminum- or calcium-containing abrasives lost 60–90% of the fluoride after one week at room temperature; sodium bicarbonate and sodium metaphosphate inactivated 20–25% after 9 months; silica was inert towards the fluoride of both sodium fluoride and MFP. A sodium fluoride paste therefore uses hydrated silica as the abrasive; calcium carbonate, dicalcium phosphate or other calcium sources (such as hydroxyapatite) are not combined with it until soluble fluoride has been assessed in that exact formula.
Humectant and structuring base
Sorbitol and glycerin keep the paste from drying out; xanthan gum or cellulose gum build structure, and thickening-grade silica keeps the paste standing on the brush. Salts can lower the viscosity of anionic polymers (background knowledge) — the order of adding sodium fluoride and the time of viscosity measurement are fixed in the process.
Foam, flavor and preservation
Sodium Lauryl Sulfate for rich foam or Cocamidopropyl Betaine for a moderate-foam, SLS-free version; mint flavor and menthol for a cool feel; xylitol and sodium saccharin for sugar-free sweetness (with no caries claim for xylitol). Sodium Benzoate in oral care products is limited to 1.7% calculated as benzoic acid (ASEAN Annex VI, Ref 1); the preservative system is challenge-tested to ISO 11930.
Key technical points
Fluorine calculation, Annex III Ref 31, soluble fluoride, evidence and safety
These are the points where a sodium fluoride toothpaste differs from a fluoride-free one; each is settled by the raw material certificate, the calculation sheet and assay results on the sample.
Converting sodium fluoride to fluorine
Labels state “ppm F” (mg fluorine per kg of product): 1,000 ppm = 0.10% F; 1,500 ppm = 0.15% F. Using the 0.4525 factor and assuming a fully pure raw material: 1,000 ppm F ≈ 0.22% NaF; 1,100 ppm ≈ 0.24%; 1,450 ppm ≈ 0.32%; 1,500 ppm (the ASEAN ceiling) — at most about 0.33% NaF (rounded down). This is a calculation; the actual level is corrected for the content on the certificate of analysis, and any other fluorine source in the formula is added to the same total.
Annex III Ref 31 — quoted exactly
ASEAN Annex III (version 2026-1, 22 June 2026), Ref 31 “Sodium fluoride”, CAS 7681-49-4: field of use “(a) Oral hygiene products (except mouthwash) (b) Mouthwash”; maximum “0.15% calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0.15%”. Labeling for (a) and (b): “Contains sodium fluoride”; (a): “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.” (footnote 12); (b): “Do not use for children below 6 years of age”. Outside oral care, Annex II Ref 191 prohibits “Hydrofluoric acid, its normal salts, its complexes and hydrofluorides with the exception of those given in Annex III, part 1” — sodium fluoride is not used in any other product.
Total fluoride and soluble fluoride
Total fluoride = soluble + insoluble fluoride; in a sodium fluoride paste, the useful part is the dissolved fluoride ion. A survey of 30 Chilean toothpastes after one year at about 22 °C: 5 products had 30–50% insoluble fluoride (4 of them used MFP with calcium-based abrasives), and soluble fluoride fell below 1,000 ppm in 2 products (Fernandez et al., 2017). In a blind crossover trial in 20 adults, a 1,100 ppm NaF/silica paste had all its fluoride in soluble form, and the amount of soluble fluoride ingested — not total fluoride — correlated with bioavailability (Falcao et al., 2013). Butter-C therefore measures soluble fluoride with an ion-selective electrode at release, during accelerated aging and in real time in the actual packaging.
Dental evidence — data on fluoride toothpaste in general
Cochrane review by Walsh et al. (2019): 96 randomized trials (published 1955–2014), most with 36-month follow-up; in the permanent teeth of children and adolescents, high- and moderate-certainty evidence that 1,000–1,250 ppm or 1,450–1,500 ppm toothpaste reduces caries increment compared with non-fluoride toothpaste, with a dose-response effect; in adults, 1,000 or 1,100 ppm toothpaste reduces caries increment (3 studies, 2,162 participants, moderate certainty). Only a minority of studies assessed adverse effects; when reported, soft tissue damage and tooth staining were minimal. The trials used various fluoride compounds — these are dental data explaining why toothpaste contains fluoride, not a claim for any specific formula.
Children: dental fluorosis and swallowing
Cochrane review by Wong et al. (2024; 43 studies, 3 randomized trials): children brushing with toothpaste of 1,000 ppm or more from age one to two until five to six probably had a higher chance of fluorosis in permanent teeth (moderate certainty); most evidence identified mild fluorosis. Wright et al. (2014): ingesting pea-sized amounts or more can lead to mild fluorosis. Whitford (2011): the most frequent sources of acute overexposure today are dental products, particularly toothpaste; a 10 kg child swallowing about 1.8 ounces (roughly 51 g) of 900–1,100 ppm toothpaste reaches the “probably toxic dose” of 5 mg/kg. This page is therefore positioned for adults, and the cap and label wording are designed to keep children from helping themselves; children’s toothpaste follows the kids’ toothpaste page.
Raw material and consumer safety
The ECHA C&L notification summary shown on PubChem classifies sodium fluoride as acutely toxic if swallowed (H301), a skin irritant (H315) and an eye irritant (H319) → a separate weighing area, gloves, safety glasses, a locked cabinet and clear warehouse labels. The ingredient dossier’s PubMed search (10/2026) found only isolated case reports, such as one year of perioral dermatitis linked to a high-fluoride toothpaste (Peters and Drummond, 2013). Butter-C has not read a CIR or SCCS conclusion specific to sodium fluoride and so does not cite one. Pregnancy and breastfeeding: the sources read contain no specific data — ask a doctor.
Three formulation directions
Three sodium fluoride toothpaste lines
Sodium fluoride – mint, rich foam
Sodium fluoride at 1,450 ppm F (about 0.32% NaF per the certificate), hydrated silica, sorbitol, glycerin, Sodium Lauryl Sulfate, mint flavor and menthol; an everyday line for adults.
Sodium fluoride – moderate foam, SLS-free
Cocamidopropyl Betaine instead of SLS, mild mint, xylitol; “SLS-free” may be stated as a description of composition; mildness assessed on the finished product.
Sodium fluoride – clear gel paste
Thickening-grade silica and a high sorbitol ratio for a clear gel; clarity, extrusion and soluble fluoride monitored across the stability time points (formulation experience, settled on the sample).
Packaging must be designed with the formula
Multilayer plastic tubes or lined aluminum tubes, screw or flip caps; there is no verified source on sodium fluoride–packaging interactions, so stability studies are run in the actual commercial packaging. Carton and tube carry the full Ref 31 wording and the 6 mm dot required by footnote (12).
Parameters we monitor
What our R&D team measures on every sample
Below is the set of parameters Butter-C monitors during formula development and scale-up. Specific limits are agreed with you on the approved sample and then written into the product’s in-house specification.
- Incoming sodium fluoride certificate
- Each lot: NaF content to correct the fluorine conversion; recalculated when the lot or supplier changes.
- Total fluorine sheet
- Fluorine from sodium fluoride and every other fluorine compound in the formula, checked against 0.15% calculated as F (Annex III Ref 31); kept in the PIF.
- Total and soluble fluoride
- Measured with an ion-selective electrode at release, during accelerated aging and in real time in commercial packaging; method agreed with the testing laboratory.
- pH
- Measured on a diluted sample by the specified method; the pH range is set from the raw material dossier and the stability results of the formula itself.
- Viscosity, extrusion
- Paste extrudes evenly, stands on the brush, does not bleed water; re-measured after adding the salt.
- Stability
- Freeze–thaw cycling and storage at 40°C; watching for water separation, hardening at the nozzle, color and flavor change, and soluble fluoride.
- Abrasivity
- Silica abrasivity index checked against the supplier’s data sheet; assessed on the finished product when a stain-cleaning claim is made.
- Microbiology & preservative challenge
- Tested at a GLP / ISO 17025-accredited laboratory; preservative efficacy (challenge) test to ISO 11930.
- Label content
- Checking “Contains sodium fluoride”, the sentence for children aged 6 and under, the 6 mm dot, and the ppm F figure matching the assay result.
Claims
Claims for a sodium fluoride toothpaste
For oral hygiene and care products, Appendix 03-MP of Circular 06/2011/TT-BYT (the ASEAN cosmetic claims guidelines) does not accept claims about preventing tooth abscess, gum disease, gingivitis, mouth ulcers, periodontitis, pus around the teeth, palatitis, misaligned teeth or oral infections, nor whitening tetracycline stains. Caries is not named in that list, but Butter-C has not concluded that “helps prevent cavities” is a permitted cosmetic claim — it awaits written confirmation from regulatory affairs. Butter-C reviews the wording on labels and promotional materials when preparing the notification dossier.
Contains fluoride, contains sodium fluoride (“helps prevent cavities” only when regulatory affairs confirms)
Instead of: gets rid of cavities, “fills cavities”, “reduces caries by 24%” borrowed from a dental review.
Cleans teeth; helps keep breath fresh
Instead of: claims to act on cavity-causing bacteria, drug-like claims about bad breath.
State the fluorine content matching the assay (e.g. 1,450 ppm F)
Instead of: “double fluoride”, “maximum fluoride” without an assay result.
Cool mint flavor
Instead of: tooth whitening, drug-like claims about sensitivity, the gums or periodontitis.
Mandatory label wording under Ref 31
“Contains sodium fluoride” and “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.”; footnote (12): applies to all toothpaste containing 0.1–0.15% fluoride unless already labeled as contra-indicated for children (e.g. “For adult use only”), and a 6 mm solid circle must appear between the words “pea sized” and “amount”. Even with adult positioning, Butter-C recommends keeping the children’s sentence because toothpaste is shared in households; the Vietnamese wording of the label is confirmed by regulatory affairs.
Warnings and intended users
Spit out after brushing, do not swallow; keep out of reach of children; a child who swallows a lot of toothpaste should be taken to a medical facility. Children use toothpaste per the kids’ toothpaste page, with concentration and amount advised by a dentist. Stop use if burning or redness appears around the mouth; persistent symptoms need a doctor or dentist. Pregnancy and breastfeeding: not enough data — ask a doctor. Instead of: “safe to swallow”, “for the whole family including babies”, “non-irritating”.
Manufacturing specifications
Current capabilities
- Textures
- White paste, clear gel paste.
- Sodium fluoride material
- In Butter-C’s current ingredient list (INCI Sodium Fluoride); each lot with a certificate of analysis; weighed and stored under a dedicated procedure for materials toxic if swallowed.
- Pack formats
- Multilayer plastic tubes, aluminum tubes, screw or flip caps. Fill weight agreed when choosing the packaging.
- Minimum order quantity
- Agreed per order and per flavor.
- Testing
- Tested at a GLP / ISO 17025-accredited laboratory, including total and soluble fluoride; certificate of analysis delivered with every batch.
- Dossier
- Product Information File (PIF) and cosmetic product notification dossier prepared by Butter-C, with the sodium fluoride certificate and the total fluorine sheet.
- Packaging
- Label design, carton, printing and packing run in parallel with formulation.
Suggested product concept
1,450 ppm sodium fluoride mint toothpaste for adults
One product concept to help you picture the possibilities — not a ready-made product for sale. The actual formula is developed around your brand’s positioning and price range.
Sodium fluoride as the named active
1,450 ppm F, within the 1,450–1,500 ppm band of the Cochrane review; about 0.32% NaF corrected per the certificate; soluble fluoride assayed every batch.
Compatible silica base
Hydrated silica for moderate cleaning, sorbitol and glycerin as humectants; no calcium-based abrasive.
Cool mint
Mint flavor with low-dose menthol, xylitol for a sugar-free aftertaste.
120 g tube and carton
Carton printed with “Contains sodium fluoride”, the child warning with the 6 mm dot, “cleans teeth, helps keep breath fresh” and the ppm F figure from the assay.
Customization options
What you can specify
The same product type can serve very different customers. Tell us your requirements in the areas below and our pharmacists will develop a matching formula.
Fluorine level
Within the 1,000–1,500 ppm range analyzed in the Cochrane review, never above 1,500 ppm (0.15% F) counting every fluorine source.
Combined fluorine sources
Adding MFP means adding the fluorine of both to one total ≤ 0.15% and stating “Contains …” for each; a calcium carbonate base goes with MFP, not with sodium fluoride (general toothpaste page).
Flavor
Strong mint, mild mint, mint–cinnamon (calculated against the IFRA ceiling, see the cinnamon toothpaste page).
Foaming agent
SLS for rich foam or Cocamidopropyl Betaine for moderate, SLS-free foam.
Fluoride-free line
See the hydroxyapatite toothpaste page; no “fluoride replacement” or “safer than fluoride” claims.
Product set
Toothpaste paired with a fluoride mouthwash: total fluorine calculated separately for each product; a sodium fluoride mouthwash carries “Do not use for children below 6 years of age” (Ref 31, item b).
Further reading
Related knowledge
Sodium fluoride in cosmetics
Dental data, the 0.15% F calculation, toothpaste amounts for children and ASEAN label warnings (in Vietnamese).
Toothpaste OEM/ODM manufacturing
General technical base for toothpaste lines; this page focuses on sodium fluoride.
Kids toothpaste OEM/ODM manufacturing
Children’s line: fluoride level by age, flavors and guidance for parents.
Hydroxyapatite toothpaste OEM/ODM manufacturing
Fluoride-free line, with comparison data against fluoride stated accurately.
Hydrated silica in cosmetics
The abrasive and thickener compatible with sodium fluoride (in Vietnamese).
Daily oral care routine
Brushing, fluoride and care steps per public recommendations (in Vietnamese).
Circular 06/2011/TT-BYT
Appendix 03-MP: claims not accepted for oral care products (in Vietnamese).
How we work
From idea to finished batch
Eight steps and three milestones signed off by both sides: approved sample, notification number, finished batch. Step-by-step details →
Get started
Tell us about the product you plan to launch
Send us your product direction and expected volume. Our team will get back to you during business hours (Vietnam time, GMT+7).
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