BUTTER-C
Medical devices
Film-forming throat spray OEM/ODM manufacturing
Throat Spray · Film-forming Throat Spray · OEM/ODM
A dry, scratchy throat after talking a lot, sitting in air-conditioned rooms or in dry weather makes many people want a compact throat spray to carry around. A film-forming throat spray works physically: a solution containing glycerin and polymers forms a thin, moisturizing film on the throat mucosa, which soothes the feeling of dryness and scratchiness. Propolis, honey, licorice or herbs play only a supporting role, giving the product its taste and story. The line to hold: claims are not tied to effects on bacteria, viruses, swelling or pain — such claims belong to drugs. A film-forming throat spray is a medical device, not a cosmetic. Butter-C advises on the formula and packaging; classification, the registration dossier and manufacturing requirements are discussed separately for each project.
Formula base
A pleasant-tasting film-forming solution
A throat spray is sprayed into the throat and partly swallowed, so every raw material must be a grade suitable for oral use.
Film forming, moisturizing
Glycerin with film-forming polymers such as HPMC, xanthan gum, carrageenan, sodium hyaluronate.
Supporting ingredients
Water-soluble propolis extract, honey, licorice, ginger — for taste and the product story.
Taste and cooling
Xylitol, sucralose; flavor and low-dose menthol for adult lines.
Preservation
A preservative system suited to a mildly acidic pH, sufficient for a bottle opened many times.
Key technical points
Four factors that determine the quality of a throat spray
Viscosity suited to the nozzle
Thick enough to stay on the mucosa yet still atomized into an even mist through the nozzle; viscosity and spray pattern measured on every batch.
Adherent film
The ratio of glycerin to polymer determines how long the film remains after swallowing.
Taste and clarity
Propolis and herbs easily turn cloudy, settle or taste bitter; choose water-soluble, alcohol-free extracts and suitable flavor solubilizers.
Microbiology
Bases with honey and sweeteners ferment easily if preservation is weak — thorough preservative efficacy (challenge) testing.
Three formulation directions
Three common types of film-forming throat spray
Glycerin and honey
A moisturizing film with a mildly sweet taste; the mainstream line for adults.
Propolis and licorice
A familiar story in the pharmacy channel; propolis and licorice in supporting roles.
Sugar-free, moisturizing
Ectoin, sodium hyaluronate, film-forming polymers; a light taste for people limiting sugar.
Packaging is planned with the formula
Pump bottles with a long swivel nozzle and a metered mist; a nozzle cap to keep out dust.
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.
- Viscosity
- Across temperatures and between batches; directly linked to the spray pattern.
- Spray pattern, dose
- Spray angle, mist fineness and the amount of solution per actuation.
- Sensory profile
- Color, odor, taste, clarity and sediment after aging.
- Microbiology
- Tested at a GLP / ISO 17025-accredited laboratory.
- Preservative performance
- Preservative efficacy (challenge) test on the final formula.
- 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. A film-forming throat spray speaks only of the film, moisture and sensation — not of bacteria, viruses, swelling or pain.
Forms a protective film on the throat mucosa
Instead of: claims of antibacterial or antiviral action in the throat.
Moisturizes and soothes the feeling of a dry, scratchy throat
Instead of: drug-like claims (gone for good, completely cleared).
Soothes the feeling of a dry, tickly throat from talking a lot or dry weather
Instead of: claims of reducing swelling or relieving sore throat pain.
Propolis, honey, licorice
Ingredient description. Instead of: attributing pharmacological effects to propolis or herbs.
Directions
Swivel the nozzle, aim it at the throat and spray the number of times stated on the label; wipe the nozzle clean after use.
Warnings
People allergic to bee products should not use versions with propolis or honey; honey is not for children under 1 year old; versions with menthol are not for young children.
Manufacturing specifications
Scope of cooperation
- Texture
- Clear or slightly viscous flavored solution.
- Format
- Pump bottles with a long swivel nozzle and a metered mist. 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
Propolis and honey film-forming throat spray
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.
Glycerin and film-forming polymers
A moisturizing film on the throat mucosa.
Propolis, honey
A mildly sweet taste and a familiar story.
Alcohol-free
Water-soluble propolis extract.
30 ml bottle with a long swivel nozzle
Compact 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.
Featured ingredients
Propolis, honey, licorice, ginger, ectoin.
Flavor
Honey, light mint, lemon-ginger, neutral.
Sugar
With honey, or sugar-free with xylitol and sucralose.
Target users
Adults; heavy voice users such as teachers, singers and customer service staff.
Documentation
An existing medical device dossier, or a new one to be prepared.
Packaging
Plastic or aluminum bottles; long swivel nozzles; cartons with a leaflet.
Further reading
Related topics
Breath freshener spray manufacturing
An oral spray in the cosmetic category.
Mouth ulcer protective gel manufacturing
A protective covering film on the oral mucosa.
Seawater nasal spray manufacturing
Another medical device spray.
Preservative efficacy testing
How preservative systems are assessed for bottles opened many times (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
Hotline +84 987 964 764 · [email protected] · Privacy policy ← Full catalog