BUTTER-C
Signature ingredients
Allantoin cream OEM/ODM manufacturing
Allantoin Cream · Signature Ingredients · OEM/ODM
Allantoin (5-ureidohydantoin) is a white, odorless powder formed when uric acid is oxidized, and it occurs naturally in tobacco seeds, sugar beet and wheat sprouts; commercial material can also be synthesized from glyoxylic acid and urea, so “allantoin” does not necessarily come from snails or any particular plant. It is a very common “soothing” ingredient: the CIR Expert Panel report (2010) recorded allantoin in 1,376 cosmetic products at concentrations up to 2%. The evidence for allantoin on its own is much thinner than its popularity: the wound data come from rats; a randomized drug trial of a 6% allantoin cream in patients with epidermolysis bullosa found it no better than the vehicle cream; the other human studies all used multi-ingredient formulas. On the formulation side, allantoin dissolves only about 0.57% in water at 25 °C — above that, a cream can contain fine particles. Butter-C's allantoin cream is therefore a gentle, fragrance-free moisturizing cream base, with the allantoin level chosen by solubility and particles checked carefully, and claims at the level of “soothes the feeling of tightness, conditions the skin” (to be tested on the finished product). Allantoin is already in the plant's raw material catalog. Butter-C offers full-service OEM/ODM manufacturing, from formula development and testing to labeled finished product with its notification dossier.
Formula base
Allantoin in a gentle moisturizing cream base
Allantoin is a small part of the formula; moisturization, softness and stability come from the emulsion base. Unlike the general moisturizer page, this page focuses on the issues that come from allantoin itself — solubility first of all.
Allantoin — a single substance, a sparingly soluble white powder
INCI “Allantoin” is a single substance (C4H6N4O3, about 158 g/mol, CAS 97-59-6 per PubChem). Allantoin ascorbate, allantoin biotin, allantoin panthenol, allantoin glycyrrhetinic acid and similar complexes have their own INCI names; CIR notes data gaps on the use levels of these complexes, so this page uses plain allantoin. The source of a raw material lot (synthetic or extracted) follows the supplier's statement.
Hydration and emollience
Glycerin, Panthenol and Sodium Hyaluronate hold water in the stratum corneum; Squalane, Caprylic/Capric Triglyceride and shea butter soften. This part carries the product's moisturizing and softening function. Glycerin only helps allantoin dissolve slightly better: per PubChem, solubility in glycerol/water 1:1 is 0.60%, versus 0.57% in water.
Emulsion base and preservation
An oil-in-water emulsion with Glyceryl Stearate – PEG-100 Stearate or an olive-derived emulsifier, Cetearyl Alcohol, Xanthan Gum or Carbomer; preservation with Phenoxyethanol (maximum 1.0% — Annex VI Ref 29) plus Ethylhexylglycerin, Disodium EDTA, and Tocopherol for the oil phase. A water-rich cream must pass a preservative efficacy (challenge) test to ISO 11930.
Points to weigh when choosing
Fragrance-free for a gentle positioning. The allantoin level is chosen by solubility and skin feel first and by the story second: the sources checked contain no human data showing that more allantoin gives better results — a randomized trial of a 6% cream was not even better than the vehicle.
Key technical points
Four points specific to putting allantoin into a cream
This is where this page differs from the general moisturizer page: the solubility, particle size, stability and regulation of allantoin itself.
Solubility of 0.57% decides its physical form
PubChem lists allantoin solubility at 25 °C: water 0.57%; ethanol 96% 0.04%; ethanol/water 1:1 0.35%; propylene glycol/water 1:1 0.40%; glycerol/water 1:1 0.60%. Inferred from these figures: in a water base at room temperature, allantoin above roughly 0.5–0.6% does not fully dissolve and remains as dispersed particles. Mixing ethanol or propylene glycol 1:1 with water does not make allantoin more soluble — it dissolves less than in water.
Checking particle size and grittiness
Below its solubility, allantoin dissolves in the water phase; above it, the material must be finely milled, mixed to homogeneity and checked for grittiness and particle size during stability testing. If it is dissolved hot at a level above its 25 °C solubility, the excess can recrystallize on cooling (an inference from the solubility data) — so above 0.5%, particles are inspected after freeze–thaw cycling. Vlad et al. (2024) describe allantoin as a suspension in xanthan gel: gel mixed by magnetic stirring had a higher quality index than gel prepared in a mortar (6.27 versus 5.45), and the allantoin gels spread less than the plain gel.
pH and temperature: set by stability testing
PubChem gives no pKa or stable pH range for allantoin, and the sources checked state no stable pH range or degradation threshold in a formula (230 °C is the melting and decomposition point of the powder). The pH range and addition temperature are fixed by stability testing: tracking pH, homogeneity, particle size, and allantoin assay if the label states a content.
Safety and regulation
CIR (Becker et al., 2010) concluded that the test data were sufficient to support the safety of allantoin and its complexes in the product categories and at the concentrations reviewed; 2% is a reported market use level, not a recommended level. We searched allantoin and CAS 97-59-6 and 5377-33-3 in ASEAN Annexes II, III and VI (06/2026 version): there is no entry. In the United States, 21 CFR 347.10 lists allantoin 0.5–2% as a skin protectant active ingredient of over-the-counter drugs — products exported to that market must clearly separate cosmetics from OTC drugs.
Three formulation directions
Three allantoin creams for three customer groups
Fully dissolved allantoin gel cream
Water-rich, low in oil, thickened with a polymer; allantoin kept within its fully dissolved range (below the 0.57% water solubility), together with glycerin, panthenol and sodium hyaluronate. Cool, fast-absorbing, no grittiness risk — for combination or oily skin that feels tight, and hot, humid climates.
Allantoin – panthenol – bisabolol moisturizing cream
An oil-in-water emulsion with squalane and triglyceride; allantoin sits with panthenol, bisabolol and dipotassium glycyrrhizate — the four-ingredient set tested together in a study on UVB-irradiated keratinocytes (Tan et al., 2024; authors from a consumer goods group). Those are cell data for the whole combination, not allantoin alone, so they are a reason for the pairing, not a claim. For normal to dry skin that easily feels tight; consistent with the bisabolol cream page.
Rich cream with dispersed allantoin
Olive-derived emulsifier, shea butter, squalane, dimethicone; allantoin used above its solubility (CIR records market use up to 2%), with the undissolved part as fine particles — a fine-particle grade is chosen per the TDS and grittiness is checked on skin. For dry skin, dry seasons and air-conditioned rooms. A higher allantoin level here is a positioning choice, not a level with evidence of greater benefit.
Packaging is designed with the formula
Tubes or pump bottles limit contact with fingers and air; wide-mouth jars are used only for rich creams, with a spatula and inner liner. Packaging is chosen after the stability results, not before.
Parameters we monitor
What our R&D lab measures on every sample
Below are the parameters Butter-C monitors during formula development and scale-up to production. Specific limits are agreed with you on the approved sample, then written into the product's in-house specification.
- Incoming raw material
- COA of each allantoin lot: identity, purity and impurities per the TDS, particle size (when used in dispersed form); synthetic or extracted source per the supplier's statement.
- Appearance & smoothness
- Color, odor and smoothness against the reference sample; particles inspected under a microscope and a rub test on skin to detect grittiness.
- pH
- Measured at 25 °C; pH drift tracked over time — the sources checked give no stable pH range for allantoin, so stability data are the reference.
- Viscosity
- Rotational viscometer, with spindle and speed recorded; matched to the tube, pump bottle or jar.
- Stability & crystallization
- Accelerated aging at 40 °C, cold storage, freeze–thaw cycling and centrifugation in the final packaging; tracking separation, allantoin crystallization, color change, odor change and pH.
- Allantoin content
- Only when the label states a content: assay at the start and after stability testing by a method agreed with the testing laboratory.
- Microbiology & challenge test
- Finished product tested at a GLP / ISO 17025-accredited laboratory; preservative efficacy (challenge) test to ISO 11930.
- Tolerance
- Patch testing and in-use testing on volunteers before the formula is locked — required if the label says “for sensitive skin” or makes a soothing claim.
- Packaging compatibility
- Filled into the actual tube, bottle or jar; tracking discoloration at the contact area, weight loss and seal integrity.
Claims
Writing claims within the cosmetic scope
CIR and PubChem classify allantoin as a skin-conditioning, soothing ingredient. In the sources checked, evidence of benefit from allantoin alone in humans is limited: in a phase 3 multicenter, randomized, double-blind trial in 169 patients with epidermolysis bullosa (aged 1 month and older), an investigational drug cream containing 6% allantoin applied to the whole body daily for 3 months was not better than the vehicle cream for time to and proportion of target wound closure, although it was well tolerated (Paller et al., 2020; the drug developer is a company and some authors belong to it). A three-ingredient gel (onion extract, heparin, allantoin) from a pharmaceutical company, compared with no product, improved self-rated scores of 61 women for cesarean-section scars after 6 weeks, while observer scores did not differ significantly (Ocampo-Candiani et al., 2014). A moisturizer with an added group of ingredients (shea butter, bacterial lysate, allantoin, bisabolol and several extracts) improved skin hydration after 14 days more than the same moisturizer without that group in adults with mild-to-moderate atopic dermatitis (double-blind trial; the abstract does not state the sample size — Prakoeswa et al., 2024). The wound data come from a 5% emulsion in rats (Araujo et al., 2010). These are a drug, a pharmaceutical product, a medical setting or animal data; Annex 03-MP of Circular 06/2011/TT-BYT does not accept drug-like claims. Below is the wording Butter-C proposes.
Soothes the feeling of tightness
A sensory claim, used once tested on the finished product. Instead of: drug-like claims about damaged skin, redness, itching or eczema.
Conditions the skin, helps skin feel soft
A function of the whole formula (glycerin, panthenol, emollients); hydration figures only when measured on the finished product. Instead of: restores skin, regenerates skin, mends skin.
Contains allantoin
An ingredient and story claim; “naturally derived allantoin” only when the supplier confirms it. Instead of: citing results of a drug trial, a pharmaceutical product or rat data as the product's benefit; “fades scars”, “keratolytic”, “ends cracked skin”.
For sensitive skin
Used only after tolerance testing on volunteers, always with an advice to test first. Instead of: non-irritating, safe for all skin types, for babies or for atopic skin.
Label advice
“Test on a small area of skin before use. Do not apply to open wounds.” The sources checked report no sensitization to allantoin; skin reactions also depend on the whole formula, so the label does not say “hypoallergenic”.
Pregnancy, young children
The sources checked have no specific recommendation on topical allantoin during pregnancy or breastfeeding — the consultation advises asking a doctor. This page is a facial cream for adults; baby products need their own formula safety assessment (see the baby moisturizer page). Instead of: safe for pregnancy.
Manufacturing specifications
Our capabilities
- Texture
- Gel cream, light cream or rich cream; milky white.
- Format
- Tube, pump bottle or jar. Volume agreed when selecting packaging.
- Allantoin raw material
- Available in the plant's raw material catalog; a COA accompanies every lot.
- Minimum order quantity
- Agreed per order — depends on the formula direction and format chosen.
- Testing
- Performed at a GLP / ISO 17025-accredited laboratory, with a certificate of analysis delivered with every batch.
- Documentation
- Product Information File (PIF) and notification dossier prepared by Butter-C, including the allantoin COA and stability results (crystallization, particle size).
- Packaging
- Label design, printing and packing run in parallel with formula development.
Suggested product concept
Fragrance-free allantoin – panthenol moisturizing cream for dry skin that easily feels tight
A product concept to help you picture the result, not a ready-made product for sale. The actual formula is developed around your brand's positioning and price range.
Allantoin
Within the fully dissolved range of the water phase (about 0.2–0.5%, from formulation experience) so the cream is smooth, not gritty; INCI “Allantoin” on the label.
Glycerin, Panthenol, Sodium Hyaluronate
The hydrating group — the basis for moisturizing and tightness-soothing claims once tested on the finished product.
Light, fragrance-free cream base
Oil-in-water emulsion, squalane, tocopherol; a short ingredient list.
50 ml tube
The label carries the patch-test advice and the note not to apply to open wounds.
Customization options
What you can specify
The same product type can serve very different customer groups. Tell us your requirements in the areas below and our pharmacists will develop the matching formula.
Allantoin level
Within the fully dissolved range (a smoother, clearer cream) or above its solubility in dispersed form (needs a fine-particle grade and stricter grittiness checks) — this decides the process and the parameters monitored.
Texture
Gel cream, light cream or rich cream; tube, pump bottle or jar.
Companion ingredients
Panthenol, Bisabolol, Dipotassium Glycyrrhizate, Sodium Hyaluronate, shea butter — chosen for the target skin type, without overloading the formula.
Fragrance
Fragrance-free (recommended for a gentle line); if fragrance is wanted, a fragrance-free version is developed in parallel.
Target users
Dry, normal or combination skin — decides the formulation direction and the tolerance testing needed. Not positioned for babies or atopic skin.
Ingredient positioning
Vegan, PEG-free, silicone-free — please state these at the start; allantoin may be a synthetic raw material, so “naturally derived” or “vegan” claims need a supplier statement and a review of the whole formula.
Further reading
Related knowledge
Allantoin in cosmetics
Origin, mechanism, how far the evidence really goes, the solubility table and how to word claims (in Vietnamese).
Moisturizing cream manufacturing
The three ingredient groups and three textures of moisturizers in general.
Bisabolol cream manufacturing
A cream named after another soothing ingredient, with the same four-ingredient cell data.
Soothing barrier essence manufacturing
A multi-ingredient essence for sensitive skin, in which allantoin is one supporting ingredient.
Dry skin and dehydrated skin
Telling oil-poor skin from water-poor skin to choose a cream texture (in Vietnamese).
Sensitive skin
Definition, triggers and how to choose cosmetics for reactive skin (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).
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