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Hydroxyapatite toothpaste OEM/ODM manufacturing
Hydroxyapatite Toothpaste · Fluoride-Free Toothpaste · OEM/ODM
Hydroxyapatite is a poorly soluble calcium phosphate from the same family of compounds as the mineral phase of enamel and dentin — which is why hydroxyapatite toothpaste is usually presented as an option for people who want a fluoride-free paste. The story is appealing, but what decides quality sits where few people look: particle shape. The EU Scientific Committee on Consumer Safety (SCCS) considers needle-shaped nano hydroxyapatite unsuitable for cosmetics, and has judged rod-shaped material safe only up to set concentrations and under strict conditions on aspect ratio and particle surface. On performance, two randomized double-blind trials found hydroxyapatite toothpaste non-inferior to a fluoride toothpaste on their predefined endpoints — dental data on specific products, not a promise to print on a cosmetic label. Fluoride remains the well-evidenced active in toothpaste; this line gives your brand a fluoride-free option, described accurately. Unlike our general toothpaste page, this page goes into what is specific to hydroxyapatite: particle data, concentrations by SCCS opinion, paste smoothness, claim limits and intended users. Butter-C offers full OEM/ODM service, from formula development and testing to finished, labeled product with its notification dossier.
Formula base
Hydroxyapatite within a complete toothpaste base
Toothpaste is a suspension: solid particles evenly dispersed in a humectant gel. Hydroxyapatite is an insoluble powder, so it becomes part of that suspension rather than dissolving like a salt-type active.
Hydroxyapatite — the right particle form
The raw material Butter-C currently holds carries the INCI name “Hydroxyapatite (nano)”; the file on hand does not yet show particle shape, aspect-ratio distribution, particle length or surface condition. Before the formula is locked, the supplier must show rod-shaped particles, no needle-shaped particles, and no coating or surface modification. If that cannot be shown, Butter-C switches to microcrystalline hydroxyapatite with a particle-size certificate confirming it is not a nanomaterial — sourced per order.
Cleaning agent
Abrasive-grade hydrated silica removes plaque and surface stains; thickening-grade silica keeps the paste standing on the brush. Abrasivity is chosen from the supplier's data sheet and measured on the finished product when a claim is made. With no fluoride there is no fluoride–abrasive compatibility constraint.
Humectant and structuring base
Sorbitol and Glycerin keep the paste from drying out; Xylitol adds a mild sweet taste and helps keep the base moist; Xanthan Gum or Cellulose Gum gives enough viscosity to keep hydroxyapatite particles from settling (formulation experience).
Foaming agents and flavor
Mild foaming agents such as Cocamidopropyl Betaine or Sodium Lauroyl Sarcosinate for an SLS-free line; mint flavor, low-dose Menthol, sugar-free sweeteners such as Sucralose. No fluorine compound of any kind is added.
Key technical points
Five things specific to hydroxyapatite toothpaste
These are the points where hydroxyapatite toothpaste differs from ordinary toothpaste; each one is settled by raw-material documentation or tests on samples.
Particle data come before the formula
SCCS/1624/20 (2021) concluded that needle-shaped nanoparticles should not be used in cosmetics and could not conclude on the rod-shaped form. SCCS/1648/22 (adopted 3/2023): safe up to 10% in toothpaste and 0.465% in mouthwash for rod-shaped particles, at least 95.8% of particles with an aspect ratio below 3 and the rest not above 4.9, no coating or surface modification. SCCS/1677/25 (adopted 6/2025): safe up to 29.5% in toothpaste and 10% in mouthwash for rod-shaped particles, at least 87% of particles with an aspect ratio of 3 or less and the rest not above 9, maximum length 122 ± 43 nm, no coating or surface modification. Each level holds only for material matching the description; these are scientific opinions, not legislation.
Concentration is not taken from advertising
The use level is chosen by the SCCS opinion the material actually meets, cost and sensory profile. The most-cited caries trials do not state the hydroxyapatite concentration in their abstracts; one 4-week sensitivity trial used a 15% nano-hydroxyapatite toothpaste (Vano et al., 2014). Butter-C therefore does not print a % figure as an “evidence-based level”.
Smooth, grit-free paste with no settling
Hydroxyapatite powder clumps when it absorbs moisture. Plant practice (internal technical file, not verified against a published source): sieve before weighing, sprinkle slowly into a vigorously stirred batch or homogenize, weigh in a draft-free area with a dust mask; check smoothness and watch for settling after aging.
Fluoride-free without fear-mongering about fluoride
The Cochrane review summarized in our oral care routine article shows that fluoride toothpaste reduces caries increment compared with non-fluoride toothpaste. A 2021 review of hydroxyapatite noted that effectiveness versus fluoride had not been established. Labels and marketing only state “fluoride-free”; they do not say “safer than fluoride” or “replaces fluoride”.
No spray formats
The 2023 SCCS opinion does not apply to spray products that could lead to inhalation of nanoparticles into the lungs, as there are no inhalation exposure data. Butter-C does not put nano hydroxyapatite into breath sprays.
Three formulation directions
Three hydroxyapatite toothpaste lines
Everyday hydroxyapatite paste
Hydroxyapatite with particle data, medium-abrasion silica, sorbitol – glycerin – xylitol base, mild mint; the core line for consumers choosing a fluoride-free paste.
Gentle paste for sensitive teeth
Low-abrasion silica, SLS-free, mild flavor. “Helps reduce the feeling of sensitivity with regular use” is written only when the product itself has been tested; for a potassium nitrate line see our sensitive toothpaste page.
Hydroxyapatite paste with zinc citrate
Zinc citrate added for a fresh-breath positioning; total zinc counted under ASEAN Annex III Ref 24 (water-soluble zinc salts, max 1% as zinc — placing zinc citrate under this entry is a cautious reading that needs regulatory confirmation); its slightly astringent taste needs flavor masking.
Packaging is designed with the formula
Multilayer plastic or aluminum tubes, screw or flip-top caps; the carton states “fluoride-free” as an ingredient description, and the ingredient list names the raw-material form according to current labeling rules (reviewed by our regulatory team when preparing the dossier).
Parameters we monitor
What our R&D lab measures on every sample
Below is the set of parameters Butter-C tracks 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 particle data
- Particle shape, number-based aspect-ratio distribution, particle length, surface condition, confirmation of no needle-shaped particles — checked against the SCCS opinion the formula relies on; repeated when the lot or supplier changes.
- Smoothness and uniformity
- No grit, no lumps; checked on fresh samples and after aging.
- Viscosity and extrusion
- Paste extrudes evenly and stands on the brush; thickening silica usually makes the paste firm up over the first days.
- Stability
- Freeze–thaw cycling, storage at 40°C; watching for syneresis, particle settling, hardening at the tube tip, color and flavor change.
- pH
- Measured on a diluted slurry by the specified method.
- Abrasivity
- Per the abrasive supplier's data sheet; measured on the finished product when a stain-removal claim is made.
- Microbiology and heavy metals
- Tested at a GLP / ISO 17025-accredited laboratory; mineral powders are a heavy-metal source to be checked against certificates of analysis.
- Packaging compatibility
- Monitoring tube liner delamination, cap leakage, paste drying at the tube mouth.
Claims
Claims for hydroxyapatite toothpaste
Toothpaste is a cosmetic. Appendix 03-MP of Circular 06/2011/TT-BYT lists as unacceptable any claims about preventing dental abscess, gumboils, mouth ulcers, periodontitis, pyorrhoea, crooked teeth, oral infections… and whitening tetracycline-induced stains. Hydroxyapatite data on caries and sensitivity are dental studies on specific products — Butter-C reports their design accurately in technical documents and does not turn them into label claims.
Cleans teeth; removes surface stains so teeth look brighter
Instead of: bleaches teeth, permanently whitens enamel, whitens tetracycline stains.
Contains hydroxyapatite mineral; fluoride-free (ingredient description)
Instead of: replaces fluoride, safer than fluoride, prevents cavities, drug-like claims about caries.
Dental trials reported by design, not placed on the label as a benefit
Adults: an 18-month randomized double-blind non-inferiority trial (margin 20%) against a 1,450 ppm sodium fluoride toothpaste; 189 people in the ITT analysis, 171 completed per protocol: 89.3% of the hydroxyapatite group and 87.4% of the fluoride group showed no DMFS increase (Paszynska et al., 2023; 3 authors are company employees). Children: a 336-day trial on primary teeth with microcrystalline hydroxyapatite (Paszynska et al., 2021). Instead of: remineralizes enamel, restores enamel, fills cavities at home.
Helps reduce the feeling of sensitivity with regular use (only with a test on the product itself)
A meta-analysis of 6 trials with 4-week follow-up (including in-office products): nano-hydroxyapatite products reduced sensitivity more than comparators for air and tactile stimuli, with no difference for cold; the authors call for longer-term data (de Melo Alencar et al., 2019). Instead of: instant sensitivity relief, drug-like claims about sensitivity.
Keeps breath fresh (when tested on the finished product)
Instead of: drug-like bad-breath claims, claims to act on odor-causing bacteria, drug-like gum claims.
Directions and intended users
Brush twice daily, spit out, do not swallow. Positioned for adults; a children's line follows our kids toothpaste page — the SCCS opinions we read contain no specific conclusion for children. Pregnancy: not enough data, ask a doctor or dentist. Ongoing caries or sensitivity needs a dentist's examination. Instead of: safe to swallow, suitable for all ages.
Manufacturing specifications
Available capabilities
- Texture
- Opaque white paste (hydroxyapatite is an insoluble powder, so the paste is not transparent); striped paste depends on equipment and order size, to be discussed.
- Pack formats
- Multilayer plastic tubes, aluminum tubes, screw or flip-top caps. Fill weight agreed when packaging is selected.
- Minimum order quantity
- Agreed per order and per flavor.
- Testing
- Performed at a GLP / ISO 17025-accredited laboratory; certificates of analysis delivered with every batch.
- Dossier
- Product Information File (PIF) including hydroxyapatite particle data checked against SCCS opinions, plus the notification dossier, prepared by Butter-C.
- Packaging
- Label design, cartons, printing and packing run in parallel with formula development.
Suggested product concept
Fluoride-free hydroxyapatite toothpaste, mild mint
A product concept to help you picture the range — not a ready-made product for sale. The actual formula is built around your brand's positioning and price point.
Hydroxyapatite with particle data
Rod-shaped, uncoated, aspect ratio matching the SCCS opinion relied on; concentration within that opinion's level.
Low-abrasion silica, SLS-free
Removes surface stains; mild foam from an amphoteric foaming agent.
Sorbitol – glycerin – xylitol base
Smooth paste, mild sugar-free sweetness, light mint.
100 g tube
Carton states “fluoride-free”, with directions to brush, spit out and not swallow.
Customization options
What you can specify
The same product type can target very different customers. Tell us your requirements in the areas below, and our pharmacists will build a matching formula.
Hydroxyapatite form
Rod-shaped nano with full particle data, or microcrystalline material that is not a nanomaterial (sourced per order, particle-size certificate).
Hydroxyapatite level
Within the level of the SCCS opinion the material meets; higher levels raise cost and thickness.
Flavor
Mild mint, strong mint, green tea, mint-free.
Foaming agent
Mild SLS-free foam, or richer foam to suit positioning.
Additional positioning
Stain removal, sensitive teeth (when tested), fresh breath with zinc.
Product set
Paired with an alcohol-free xylitol mouthwash in a fluoride-free oral care set.
Further reading
Related knowledge
Hydroxyapatite in cosmetics
SCCS opinions on the nano form, trials against fluoride and ASEAN regulation (in Vietnamese).
Toothpaste OEM/ODM manufacturing
General technical base, fluoride lines and mandatory label warnings.
Sensitive toothpaste OEM/ODM manufacturing
Actives for sensitive teeth, including hydroxyapatite.
Xylitol mouthwash OEM/ODM manufacturing
The companion product in a fluoride-free oral care set.
Daily oral care routine
Brushing, fluoride, mouthwash and dental visits per public guidance (in Vietnamese).
Hydrated silica in cosmetics
RDA abrasivity and stain removal of the main cleaning agent (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 (in Vietnamese) →
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).
Head office: Huu Le village, Dai Thanh commune, Hanoi · Factory: Thanh Oai Industrial Cluster, Binh Minh commune, Hanoi, Vietnam
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