BUTTER-C
Medical devices
Multi-purpose barrier cream OEM/ODM manufacturing
Multi-purpose Barrier Cream · Skin Protectant Cream · OEM/ODM
A multi-purpose barrier cream is the cream kept at home for everyday situations: dry, cracked skin, areas rubbed by chafing, and the itching or stinging feeling after insect bites. The cream works physically: it forms a protective film that reduces water loss, limits contact with external irritants and keeps the stratum corneum moisturized, which helps reduce discomfort and soothes the feeling of itching and stinging. The cream contains no corticosteroids, antihistamines, numbing agents or other active pharmaceutical ingredients — adding any of these turns the product into a drug. When the intended use is to form a protective film over uncomfortable skin, the product is a medical device under Decree 98/2021/ND-CP (as amended and supplemented by Decree 07/2023/ND-CP), classified according to the rules depending on the site of use and contact duration; if it only provides ordinary moisturizing, it is 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
An emulsion cream rich in film formers
A multi-purpose barrier cream is an emulsion with a high proportion of film formers: the film must be durable enough to protect, yet still spread thinly without stickiness.
Occlusive film formers
Petrolatum, dimethicone, lanolin — reduce transepidermal water loss and friction.
Covering powder
Zinc oxide forms a physical covering layer that helps keep moist, chafed skin dry and airy; its level determines how white the cream is.
Moisturizing and soothing
Glycerin, panthenol, allantoin, fine colloidal oatmeal, bisabolol.
Emulsification and preservation
Oil-in-water or water-in-oil emulsion with a gentle emulsifier system; low-level preservation, fragrance-free.
Key technical points
Four factors that determine the quality of a multi-purpose barrier cream
Durable but non-sticky film
Balance petrolatum and dimethicone against the water phase so the cream spreads thinly with little greasy shine.
Even powder dispersion
Zinc oxide must be thoroughly dispersed; no clumping and no oil separation after aging.
No stinging
Alcohol-free, fragrance-free, essential-oil-free; suitable for dry, cracked, sensitive skin.
Product boundaries
No corticosteroids, antihistamines or numbing agents — adding them makes it a drug. Not for open wounds or burns.
Three formulation directions
Three common types of multi-purpose barrier cream
Petrolatum and dimethicone film cream
Protects dry, cracked skin and chafed areas; for the whole family.
Zinc oxide cream
A white covering layer that helps keep moist, chafed skin dry and airy.
Soothing oatmeal cream
Colloidal oatmeal, panthenol, bisabolol; helps soothe the feeling of itching from dry skin and insect bites.
Packaging is planned with the formula
Small tubes to carry, jars for the family; small-opening tubes limit contamination.
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, spreadability
- Across temperatures; the cream must spread easily even in cold weather.
- Emulsion stability
- Centrifugation, freeze–thaw cycling; no oil separation, no powder clumping.
- Microbiology
- Tested at a GLP / ISO 17025-accredited laboratory.
- Preservative performance
- Preservative efficacy (challenge) test on the final formula, especially for jars opened many times.
- Skin tolerance
- Irritation assessment according to the dossier; biocompatibility usually with reference to the ISO 10993 series.
Claims
Writing claims based on the film-forming mechanism
The intended use stated on the label determines whether the product is a medical device or a cosmetic, and its classification. Claims describe only the mechanism of the film.
Forms a protective film, moisturizes dry, cracked skin
Instead of: drug-like claims (gone for good, completely cleared).
Helps soothe the feeling of itching from dry skin and insect bites
Instead of: anti-allergy or anti-swelling claims.
Helps reduce discomfort from chafing
Instead of: claims of repairing damaged skin.
Corticoid-free, fragrance-free
State only the ingredients actually present.
Directions
Apply a thin layer to clean, dry skin; reapply as needed.
Warnings
For external use only; do not use on open wounds; discontinue use if irritation occurs; consult a medical professional if the condition persists.
Manufacturing specifications
Scope of cooperation
- Texture
- Soft emulsion cream, thick soft-wax cream.
- Format
- Tubes, jars. Volume agreed during packaging selection.
- Product category
- Medical device or cosmetic, depending on the intended use stated on the label; for a medical device, classification follows the 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 for the medical device route.
- Minimum order quantity
- Agreed per order.
- Packaging
- Label design following the mandatory content for the product category, printing and packing.
Suggested product concept
Zinc oxide and oatmeal protective film cream
A product concept to help you picture the possibilities — not a ready-made product for sale. The actual formula is developed according to the dossier of the chosen product category.
Petrolatum and dimethicone
Protective film, moisture.
Zinc oxide
Covers and helps keep chafed skin dry and airy.
Colloidal oatmeal, panthenol
Helps soothe the feeling of itching from dry skin.
Small tube, fragrance-free
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.
Use situations
Dry, cracked skin, insect bites, chafing.
Users
Adults, children, the elderly — determines how minimal the formula is.
Texture
Soft cream, thick cream; white or off-white.
Featured ingredients
Zinc oxide, oatmeal, panthenol.
Documentation
Medical device or cosmetic; an existing dossier, or a new one to be prepared.
Packaging
Tubes, jars, family sets.
Further reading
Related topics
Foot cream manufacturing
Cream for thick, dry, cracked skin.
Hand cream manufacturing
Moisturizing cream for dry hands.
Nano silver gel and cream manufacturing
A topical cream on a different dossier route.
Preservative efficacy testing
How preservative systems are tested for creams in jars (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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