BUTTER-C
Medical devices
Personal lubricant gel OEM/ODM manufacturing
Personal Lubricant Gel · Water-based & Silicone-based Lubricant · OEM/ODM
A personal lubricant helps reduce friction and the feeling of dryness during intercourse, used alone or with condoms. The gel achieves its purpose through physical lubrication and contacts the mucosa directly, so it is not a cosmetic but a medical device under Decree 98/2021/ND-CP (as amended and supplemented by Decree 07/2023/ND-CP). Three things determine quality: whether the base is water or silicone; compatibility with latex condoms — mineral and vegetable oils weaken latex, so oil-based gels are not used with condoms; and osmolality and pH suited to the mucosa. Classification depends on the intended use, the site of use and whether the product is used with condoms, and is carried out by a qualified person or organization according to the classification rules. Butter-C advises on the formula and packaging; classification, the registration dossier and manufacturing requirements are discussed separately for each project.
Formula base
Water-based or silicone-based — never oil-based
Choosing the base is the first decision: water-based gels rinse off easily and work with all types of condoms; silicone-based gels stay slippery longer without drying out; oil-based gels are not compatible with latex condoms.
Water-based
Hydroxyethylcellulose, HPMC, xanthan or carbomer form a clear gel; glycerin moisturizes at a moderate level.
Silicone-based
A blend of dimethicones of different viscosities, dimethiconol — long-lasting glide, non-volatile, does not weaken latex.
pH buffer
Lactic acid and sodium lactate keep water-based gels at a mildly acidic pH.
Preservation
Water-based gels need a low-level preservative system suited to acidic pH; anhydrous silicone gels need little preservation.
Key technical points
Five factors that determine the quality of a personal lubricant
Condom compatibility
Tested with latex condoms (and polyisoprene or polyurethane if stated on the label); no mineral oils, vegetable oils or oil esters.
Osmolality
High levels of glycerin or propylene glycol make the gel hyperosmotic, drawing water out of the mucosa; humectant levels are balanced against measured osmolality.
pH
Suited to the site of use; buffered to keep the pH stable throughout the shelf life.
Feel in use
Slippery, non-sticky, slow to dry; a water-based gel can be refreshed with a little water.
Compatibility with accessories
Silicone gels can damage the surface of silicone accessories — state a warning on the label.
Three formulation directions
Three common types of personal lubricant
Water-based cellulose gel
Clear, non-sticky, easy to rinse; works with all types of condoms.
Moisturizing water-based gel
With added hyaluronate and aloe vera; a longer-lasting moist feel, still formulated to osmolality.
Silicone-based gel
Dimethicone; long-lasting glide, water-resistant; harder to rinse off than water-based gels.
Packaging is planned with the formula
Pump bottles, tubes, single-use sachets; pumps that do not leak when turned upside down.
Parameters we monitor
What our R&D lab measures on every sample
Below are the parameters monitored during formula development. Parameters for the medical device dossier are applied according to the relevant standards and regulations.
- pH
- Measured at manufacture and after aging (water-based gels).
- Osmolality
- Measured on the finished gel; a key parameter for gels in contact with the mucosa.
- Viscosity, slipperiness
- Across temperatures and between batches.
- Condom compatibility
- Latex condom strength tested before and after exposure to the gel.
- Microbiology
- Tested at a GLP / ISO 17025-accredited laboratory; preservative efficacy (challenge) test for water-based gels.
- Packaging compatibility
- Pumps and sachets do not leak after aging.
Claims
Writing claims based on lubrication, in line with the medical device dossier
The intended use stated on the label determines the product's classification and dossier. State "condom compatible" only when test results are available.
Lubricates, reduces friction and the feeling of dryness during intercourse
Instead of: claims of enhanced pleasure, prolonged duration or effects on sexual function.
Compatible with latex condoms
Instead of: stating compatibility without testing on the exact type of condom.
Water-based, easy to rinse; fragrance-free, color-free
State only the ingredients actually present.
Not a contraceptive
State clearly on the label; make no claims of preventing the transmission of infections.
Directions
Apply a sufficient amount and reapply as needed; rinse water-based gel off with water.
Warnings
Discontinue use if irritation occurs; do not use silicone gel with silicone accessories; keep out of reach of children.
Manufacturing specifications
Scope of cooperation
- Texture
- Clear aqueous gel; anhydrous silicone gel.
- Format
- Pump bottles, tubes, single-use sachets. Volume agreed during packaging selection.
- Product category
- Medical device — not covered by the cosmetic product notification; classification follows the rules, depending on 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.
- Quality system
- With reference to the ISO 13485 quality management system; biocompatibility is usually assessed according to the ISO 10993 series.
- Minimum order quantity
- Agreed per order.
- Packaging
- Label design following the mandatory content for medical devices, printing and discreet packing.
Suggested product concept
Clear water-based lubricant, latex compatible
A product concept to help you picture the possibilities — not a ready-made product for sale. The actual formula is developed in line with the medical device dossier.
Cellulose base
Clear, non-sticky, easy to rinse.
Moderate glycerin
Moisturizes; adjusted to osmolality.
Mildly acidic pH
Lactic acid buffer.
Pump bottle and small sachets
A bottle for home use, small sachets to carry.
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.
Base
Water-based, silicone-based.
Feel
Thin or thick, slipperiness, how long the glide lasts.
Featured ingredients
Hyaluronate, aloe vera (water-based).
Scent
Fragrance-free (recommended).
Documentation
An existing medical device dossier, or a new one to be prepared.
Packaging
Pump bottles, tubes, sachets; discreet design.
Further reading
Related topics
Feminine gel pen manufacturing
Single-dose moisturizing gel for the vaginal area.
Intimate care gel manufacturing
The line between cosmetic gels and medical device gels.
Ultrasound gel manufacturing
Another medical device gel.
Preservative efficacy testing
How preservative systems are tested for water-based gels (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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