BUTTER-C
Medical devices
Seawater nasal spray OEM/ODM manufacturing
Seawater Nasal Spray · Isotonic & Hypertonic Nasal Spray · OEM/ODM
Rinsing the nose with saline or seawater is a habit in many families, especially in dry weather, in dusty air or when the nose is full of mucus. A seawater nasal spray makes this easier: an even mist or jet mechanically rinses away dust and mucus and moisturizes the nasal mucosa. The challenge lies in cleanliness and packaging: the solution must be filtered, sterilized and filled into a sealed container that keeps air from flowing back in, so it usually needs no preservative. A clear distinction is needed: a seawater nasal spray on the medical device route differs from the many 0.9% sodium chloride saline products marketed as drugs — the two categories have different dossiers, labels and manufacturing requirements. Butter-C advises on the formula and packaging; classification, the registration dossier and manufacturing requirements are discussed separately for each project.
Formula base
Purified seawater, with a salt concentration matched to the purpose
A seawater nasal spray has very few ingredients; quality lies in the seawater source, the salt concentration and the cleanliness of the solution.
Seawater
Filtered seawater with documented origin, controlled for heavy metals and microbiology; diluted with purified water to the target concentration.
Salt concentration
Isotonic (equivalent to body fluids) for daily use; hypertonic (more concentrated) for when the nose has a lot of mucus and feels congested.
Moisturizing ingredients
Optional: sodium hyaluronate, ectoin, adhesion-enhancing polymers such as HPMC — only in a role of moisturizing the mucosa.
Preservation
Usually preservative-free thanks to a sterilized solution and a sealed one-way container.
Key technical points
Four factors that determine the quality of a seawater nasal spray
Solution cleanliness
Membrane filtration, sterilization (sterile filtration or heat) and filling under controlled conditions; sterility or microbial limits as stated in the dossier.
Consistent concentration
Salt assay, osmolality and pH measured on every batch so the spray feels the same as the approved sample.
Sealed one-way container
A bag-on-valve can or a pump with a one-way valve that keeps air and liquid from flowing back in — keeping the solution clean until the last use without preservatives.
Spray pattern
Fine mist for young children, a stronger jet for rinsing; a nozzle with a stopper ridge so it is not inserted too deep into the nose.
Three formulation directions
Three common types of seawater nasal spray
Isotonic for daily use
Cleanses and moisturizes the nasal mucosa; the mainstream line for the whole family, with a dedicated nozzle for young children.
Hypertonic
A higher salt concentration that helps thin and rinse away mucus when the nose feels congested; may cause mild stinging, use as directed on the label.
Isotonic with moisturizing ingredients
Added sodium hyaluronate or ectoin for noses dried out by air conditioning or dry weather — classification is determined by the intended use.
Packaging is planned with the formula
Continuous-spray bag-on-valve cans, pump bottles with a one-way valve; different nozzles for young children and adults.
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.
- Sodium chloride content
- Assayed on the finished product, on target for isotonic or hypertonic.
- Osmolality, pH
- Measured at manufacture and after aging.
- Clarity
- No turbidity, no sediment, no foreign particles.
- Microbiology
- Sterility or microbial limits according to the dossier; tested at a GLP / ISO 17025-accredited laboratory.
- Heavy metals
- Tested on the seawater source and on the finished product.
- Packaging
- Container seal, bag-on-valve can pressure, spray pattern and amount per actuation.
- Biocompatibility
- Assessment of irritation, sensitization and cytotoxicity — usually with reference to the ISO 10993 series.
Claims
Writing claims in line with the medical device dossier
The intended use stated on the label determines classification and the dossier. The function of a seawater nasal spray is mechanical rinsing and moisturizing — not tied to any effect on bacteria or viruses.
Nasal hygiene: mechanically rinses away dust and mucus
Instead of: claims of antibacterial action in the nose.
Moisturizes a dry nasal mucosa
Instead of: drug-like claims (gone for good, completely cleared).
Helps clear the nose by thinning mucus (hypertonic line)
Instead of: claims of reducing swelling or constricting blood vessels like a decongestant nasal drug.
Purified, isotonic seawater
Ingredient description. Instead of: calling it 0.9% sodium chloride physiological saline when the product does not belong to that category.
Directions
Tilt the head, insert the nozzle into the nostril, spray and let the liquid drain out; wipe the nozzle clean after use; one bottle per person.
Warnings
Young children use the child nozzle, with an adult administering; discontinue use if discomfort persists; keep out of reach of children.
Manufacturing specifications
Scope of cooperation
- Texture
- Clear, colorless aqueous solution.
- Format
- Bag-on-valve cans, pump bottles with a one-way valve. Volume 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, contact duration and site of use; official classification follows the classification rules.
- Legal basis
- Decree 98/2021/ND-CP on the management of medical devices, as amended and supplemented by Decree 07/2023/ND-CP.
- Manufacturing and documentation
- Classification, the registration dossier and manufacturing requirements are discussed separately for each project.
- Minimum order quantity
- Agreed per order.
- Packaging
- Label design following the mandatory content for medical devices, printing and packing.
Suggested product concept
Isotonic seawater nasal spray for the family
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.
Purified isotonic seawater
Rinses away dust and mucus; moisturizes the mucosa.
Preservative-free
Thanks to a sterilized solution and a sealed one-way container.
Fine-mist bag-on-valve can
Sprays evenly at any angle.
Two nozzles
A nozzle with a stopper ridge for young children and a nozzle for adults.
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.
Concentration
Isotonic or hypertonic.
Added ingredients
None, or sodium hyaluronate or ectoin in a moisturizing role.
Target users
Young children, adults, the whole family.
Spray pattern
Fine mist, rinsing jet, continuous spray.
Documentation
An existing medical device dossier, or a new one to be prepared.
Packaging
Bag-on-valve cans, pump bottles with a one-way valve, small sizes to carry.
Further reading
Related topics
Salt mouth rinse manufacturing
The line between cosmetic salt water and physiological saline.
Facial mist manufacturing
Mineral water and seawater used in facial cosmetics.
Film-forming throat spray manufacturing
Another medical device spray.
Microbial control in manufacturing
The foundation for preservative-free 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 (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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