BUTTER-C
Medical devices
Feminine gel pen OEM/ODM manufacturing
Feminine Gel Pen · Single-dose Intimate Moisturizing Gel · OEM/ODM
A feminine gel pen is a gel filled in a single-dose applicator with a long nozzle, delivering a preset amount of gel into the vaginal area cleanly and discreetly. The gel moisturizes, forms a lubricating film and has a lactic acid base that helps maintain a mildly acidic pH environment — all physical and physicochemical mechanisms, not pharmacological action. Because it is used internally and contacts the mucosa, a feminine gel pen is not a cosmetic but a medical device under Decree 98/2021/ND-CP (as amended and supplemented by Decree 07/2023/ND-CP). It is usually classified as class A or B depending on the intended use, residence time and site of use; official classification is carried out by a qualified person or organization according to the classification rules. It should be distinguished from intimate care gel — a cosmetic for external use only. Butter-C advises on the formula and single-dose packaging; classification, the registration dossier and manufacturing requirements are discussed separately for each project.
Formula base
A minimal, mildly acidic, fragrance-free aqueous gel
A feminine gel pen uses a minimal aqueous gel base; every ingredient must be justified when it contacts the mucosa. No fragrance, colorants or essential oils.
Gelling and mucoadhesive agents
Hydroxyethylcellulose, carbomer or polycarbophil — a clear gel that adheres to the mucosa and keeps the film in place longer.
Humectants
Glycerin, hyaluronate — hold water in the gel layer; the amount of glycerin is calculated together with the gel's osmolality.
pH buffer
Lactic acid and sodium lactate form a mildly acidic buffer, close to the natural environment of the vaginal area.
Preservation
Sealed single-dose applicators help reduce the amount of preservative; where needed, a preservative suited to acidic pH is chosen at a low level.
Key technical points
Five factors that determine the quality of a feminine gel pen
Osmolality
A gel overloaded with humectants becomes hyperosmotic and draws water out of the mucosa; glycerin and propylene glycol levels are set by measured osmolality, not by feel alone.
pH and buffer capacity
Mildly acidic pH, with enough buffer capacity to keep the pH stable throughout the shelf life.
Consistent dose per applicator
Uniform fill volume, a plunger that expels all the gel, and a medium viscosity that does not flow back.
Microbiological cleanliness
Compounding and filling under clean conditions; applicators and gel are sterilized if the dossier states the product is sterile.
Biocompatibility
Both the gel and the applicator material contact the mucosa; assessment usually follows the ISO 10993 series (cytotoxicity, irritation, sensitization).
Three formulation directions
Three common types of feminine gel pen
Daily moisturizing gel
Hyaluronate and glycerin on a cellulose base; helps moisturize a dry vaginal area.
Mildly acidic pH gel
Lactic acid and sodium lactate on a carbomer base; helps maintain a balanced pH environment, used after menstruation or after intercourse.
Long-lasting mucoadhesive gel
Polycarbophil forms a long-lasting adherent film, used every other day — a longer residence time affects classification.
Packaging is planned with the formula
Single-dose applicators with a nozzle and plunger; materials in contact with the mucosa must have supporting documentation.
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 and buffer capacity
- Measured at manufacture and after aging.
- Osmolality
- Measured on the finished gel; the basis for adjusting humectant levels.
- Viscosity
- Across temperatures; affects the force needed to push the plunger.
- Weight per applicator
- Uniformity of fill weight and of the amount of gel that can be expelled.
- Microbiology or sterility
- According to the criteria in the dossier; tested at a GLP / ISO 17025-accredited laboratory.
- Packaging compatibility
- Applicator, plunger and nozzle after aging: no leaks, no deformation.
Claims
Writing claims by mechanism, in line with the medical device dossier
The intended use stated on the label determines the product's classification and dossier. Claims describe only the gel's mechanisms: moisturizing, lubrication and pH buffering.
Helps moisturize a dry vaginal area
Instead of: drug-like claims (gone for good, completely cleared).
Forms a lubricating film, soothes the feeling of dryness and stinging
Instead of: claims about infections, yeast or vaginal discharge.
Helps maintain a mildly acidic pH environment
Instead of: claims of antibacterial action on the body or of preventing recurrence.
Fragrance-free, color-free
State only the ingredients actually present.
Directions
Each applicator is for single use: insert the nozzle, push out all the gel, discard the applicator after use.
Warnings
Discontinue use if irritation occurs; consult a medical professional if there are unusual signs or during pregnancy; keep out of reach of children.
Manufacturing specifications
Scope of cooperation
- Texture
- Clear aqueous gel, medium to high viscosity.
- Format
- Single-dose applicators with a nozzle, several per box. Volume per applicator agreed during packaging selection.
- Product category
- Medical device — not covered by the cosmetic product notification. Usually classified as class A or B depending on the intended use and residence time; official classification follows the classification rules.
- 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
Hyaluronate moisturizing gel pen with a mildly acidic pH
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.
Hyaluronate and glycerin
Moisturize and lubricate; adjusted to osmolality.
Lactic acid
Mildly acidic pH buffer.
Fragrance-free, color-free
Kept minimal for the mucosa.
Box of single-dose applicators
Smooth nozzle tip; each applicator is used once.
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.
Purpose
Daily moisturizing, pH balance support, lubrication.
Frequency of use
Daily or every other day — affects the gel base and classification.
Volume per applicator
According to the desired dose.
Microbiological criteria
Microbiologically clean or sterile — determines the process and packaging.
Documentation
An existing medical device dossier, or a new one to be prepared.
Packaging
Applicator, nozzle, box; discreet design.
Further reading
Related topics
Intimate care gel manufacturing
A cosmetic gel for external use only — where it differs from a feminine gel pen.
Feminine wash manufacturing
External cleansing of the intimate area.
Personal lubricant gel manufacturing
A gel in contact with the mucosa, also a medical device.
Ultrasound gel manufacturing
Another medical device gel.
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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