BUTTER-C
Medical devices
Nano silver gel and cream OEM/ODM manufacturing
Nano Silver Gel & Cream · Colloidal Silver Topical Gel · OEM/ODM
Nano silver consists of nanometer-sized silver particles dispersed in water, usually yellow to brown depending on particle size. For nano silver gels and creams, the first thing to settle is not the formula but the dossier category. When silver is included for an antibacterial role, the product is usually not class A: under the medical device classification rules of Decree 98/2021/ND-CP (as amended and supplemented by Decree 07/2023/ND-CP), a product in which a medicinal substance plays a supporting role is usually placed in a higher risk class and may require marketing authorization registration. On the cosmetic route, silver may only be used within permitted limits and the label may not claim antibacterial action on the skin; where the primary action is pharmacological, the product is a drug. Technically, nanoparticles readily agglomerate and discolor on contact with salts, light or reducing agents, so the gel base and packaging must be chosen around the silver. Butter-C advises on the formula and packaging; classification, the registration dossier and manufacturing requirements are discussed separately for each project.
Formula base
A gel or cream base chosen around the silver particles
The silver nanoparticles dictate the base: no ingredient may cause the particles to agglomerate or discolor.
Nano silver dispersion
A dispersion from the supplier, with documentation of particle size, silver concentration and stabilizer (typically PVP or citrate).
Gelling agents
Hydroxyethylcellulose, non-ionic polymers — little effect on the particles' surface charge; carbomer can be used but must be stability-tested.
Humectants
Glycerin, panthenol, hyaluronate — form a moisture-retaining film on the skin.
Cream base
Oil-in-water emulsion with non-ionic emulsifiers; avoid cationic emulsifier systems and high electrolyte levels.
Preservation
A separate preservative system that does not rely on silver; compatibility with the nanoparticles is tested.
Key technical points
Five factors that determine the quality of a nano silver gel or cream
Particle stability
Chloride salts, strong electrolytes, sulfur compounds, reducing agents and oxidizing agents make the particles agglomerate and turn the gel gray-black; they are kept out of the formula.
Particle size
Particle size distribution is measured on the raw dispersion and on the finished product after aging.
Silver concentration
Total silver is assayed in every batch and must match the level stated in the dossier.
Light and packaging
Nano silver is light-sensitive: use aluminum tubes or light-blocking packaging, and avoid metal in direct contact with the gel.
Order of addition
The silver dispersion is added during the cool-down phase, with gentle stirring, after pH adjustment.
Three formulation directions
Three dossier routes, three ways to formulate
For the same gel containing nano silver, different dossier routes lead to different formulas, silver concentrations, required data and labeling. The dossier route is decided before sampling.
Medical device
The intended use is declared by the product owner, and classification follows the rules. In an antibacterial role, silver usually takes the product out of class A, and it may require marketing authorization registration (class C, D).
Cosmetic
Silver is used only within permitted limits, and the nano form requires its own safety data; the label makes no antibacterial claim on the skin — the claims are moisturizing and skin care.
Drug
Where the primary action is pharmacological, the product is a drug and falls under separate drug regulations — outside the scope of this page.
Dosage form
Clear gel on a cellulose base, non-ionic emulsion cream, moisturizing gel with panthenol — chosen after the dossier route is decided.
Parameters we monitor
What our R&D lab measures on every sample
Below are the parameters monitored during formula development. Parameters for the dossier are applied according to the standards and regulations of the chosen product category.
- Particle size
- Size distribution on the raw material and on the finished product after aging.
- Silver content
- Total silver assayed in each batch.
- Color
- Compared with the reference sample; discoloration signals agglomeration.
- pH, viscosity
- At manufacture and after aging.
- Microbiology
- Tested at a GLP / ISO 17025-accredited laboratory.
- Packaging compatibility
- Light-blocking tube; the gel at the tube opening does not discolor.
Claims
Claims follow the chosen dossier route
For the same formula, the permitted claims differ greatly between a medical device, a cosmetic and a drug. Decide the dossier route first, then write the label.
Forms a protective film, keeps the skin area moisturized
Instead of: drug-like claims (gone for good, completely cleared).
The role of silver stated according to the medical device dossier
Instead of: claims of antibacterial action on the body without the corresponding classification and dossier.
Cosmetic: cares for and moisturizes the skin
Instead of: antibacterial claims for the skin on a cosmetic label.
Silver content
State exactly as in the dossier; do not state particle size unless it has been measured on the finished product.
Directions
Apply a thin layer to clean skin.
Warnings
For external use only; avoid the eyes; discontinue use if irritation occurs; do not use over large areas for prolonged periods without consulting a medical professional.
Manufacturing specifications
Scope of cooperation
- Texture
- Clear aqueous gel, emulsion cream.
- Format
- Aluminum tubes, light-blocking plastic tubes, pump bottles. Volume agreed during packaging selection.
- Product category
- Medical device, cosmetic or drug, depending on the role of silver and the intended use.
- Documentation
- Class A and B: declaration of applicable standards; class C and D: marketing authorization registration. Classification, the registration dossier and manufacturing requirements are discussed separately for each project.
- Silver raw material
- A nano silver dispersion with supplier documentation: particle size, concentration, stabilizer, safety data.
- Minimum order quantity
- Agreed per order.
- Packaging
- Label design following the mandatory content for the product category, printing and packing.
Suggested product concept
Moisturizing nano silver gel on a cellulose base
A product concept to help you picture the possibilities — not a ready-made product for sale. The actual formula is developed according to the chosen dossier route.
Nano silver dispersion
Content according to the chosen dossier route.
Clear HEC base
Non-ionic, with little effect on the silver particles.
Panthenol, glycerin
Moisturize and form a film.
Small aluminum tube
Light-blocking, with a small opening.
Customization options
What you can specify
Within the same product type, each brand targets a different group of users. Tell us your requirements in the areas below, and our team of pharmacists will advise on a matching solution.
Dossier route
Medical device or cosmetic; an existing dossier, or a new one to be prepared.
Form
Clear gel, cream.
Silver source
A silver dispersion you specify, or a supplier proposed by Butter-C.
Supporting ingredients
Panthenol, hyaluronate, aloe vera.
Sales channel
Pharmacies, clinics, retail.
Packaging
Aluminum tubes, light-blocking tubes.
Further reading
Related topics
Multi-purpose barrier cream manufacturing
A protective film-forming cream without silver.
Ultrasound gel manufacturing
Another medical device gel.
Cosmetic labeling rules
Limits on claims on cosmetic labels (in Vietnamese).
Cosmetic PIF dossiers
Safety assessment on the cosmetic route (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).
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