PETROLATUM
What is PETROLATUM (CAS 8009-03-8) in cosmetics and what are its global regulatory limits?
PETROLATUM (CAS No. 8009-03-8) is a verified cosmetic ingredient primarily functioning as Antistatic, Emollient in topical formulations. Regulated under KR MFDS (Labelling / Claim) and EU 1223/2009 CosIng (Prohibited) statutory frameworks, it is typically formulated at 2–18% within an optimal stability window of pH 4–8.
7-Track Official Regulatory Label Names Matrix
Primary Statutory Gazette Only · Zero Machine Translation| Jurisdiction Track | Official Statutory Label Name | One-Click Copy |
|---|---|---|
| 1. Korea (MFDS Standard Name) | PETROLATUM (KR MFDS Registered) | |
| 2. Korea Former Nomenclature History | — | — |
| 3. European Union (EU CosIng Glossary) | PETROLATUM | |
| 4. United States (US PCPC / MoCRA INCI) | PETROLATUM | |
| 5. US FDA OTC Monograph Active Name | PETROLATUM | |
| 6. China (NMPA IECIC Standard Name) | 矿脂 | |
| 7. Japan (JCIA Standard / MHLW Quasi-Drug) | ワセリン · [QD: 白色ワセリン] |
Layer 1 — Statutory Regulatory Limits Across 6 Regions
| Region | Status | Max Limit | Conditions & Statutory Source |
|---|---|---|---|
| Europe (EU) | Prohibited | — | Permitted within statutory scope Source: Regulation (EC) No 1223/2009 Annex II — via CosIng (EU Commission) |
| Korea (MFDS) | Labelling / Claim | — | Permitted within statutory scope Source: MFDS Cosmetic Safety Standards Notice |
| China (NMPA) | Labelling / Claim | — | Permitted within statutory scope Source: 化妆品安全技术规范(2015 Ed.) — 表1 |
Layer 3 Formulation Concentration Box-Plot vs. Statutory Limit
Layer 3 — Formulation Usage Guide (Quartiles n≥5) & Physicochemical Compatibility
| Formulation Group | Min – Q1 – Median – Q3 – Max (%) | Role & Mechanism | Source ID |
|---|---|---|---|
| Group B — O/W & W/O Emulsion / Lotion / Cream | 2% · 4% · 4.55% · 7.275% · 18% | Emulsion cream & lotion structural / conditioning agent | Global Starter Formulation Library Statistical Distribution (n=11, EVONIK 10 · SEPPIC 1) |
Stratum Corneum Penetration Depth & Bio-Spicule Transdermal Delivery
Under passive topical application, molecules diffuse tortuously through intercellular lipids. Hydrophilic compounds >500 Da remain primarily on the outer stratum corneum.
pH Stability Window (0–14), Thermal Limit & HLB Colloidal Phase Behavior
Outside pH 4–8, risk of hydrolysis, viscosity loss, or ionic dissociation increases.
Thermally stable up to 50°C during standard emulsification.
Cellular & Molecular Target Mechanism Flow
Interactive Synergy Pairings (Solid) & Incompatibility Warnings (Dashed)
Click any green synergy node to jump directly to its monograph, or click a red dashed node to inspect the chemical incompatibility mechanism.
Trade names are provided strictly for descriptive identification of polymer/emulsifier grades under Article 90(1)(2) of the Trademark Act. All trademarks belong to their respective owners.
Academic & Toxicological Synthesis
Tier 1 SynthesisSynthesized strictly from peer-reviewed PubMed abstracts and official toxicological dossiers linked to this ingredient.
Linked Peer-Reviewed Literature (NIH PubMed) (12)
Antibacterial activity of glycerol monolaurate formulated in petrolatum [PMID: 42300754 · 2026]
Glycerol monolaurate (GML) is a fatty acid monoester of glycerol that is approved by the FDA as a food additive and component of cosmetics. We previously showed that 50,000 µg/mL of GML solubilized in the non-aqueous K-Y Warming Gel is broadly antibacterial, including S. aureus and various streptococcal species, and selectively increases beneficial lactobacilli. GML is also anti-inflammatory, reducing harmful inflammation. In the current study, we examined GML and longer or shorter fatty acid monoesters for their anti-staphylococcal activity. GML had the greatest anti-staphylococcal activity. We then showed in vitro that GML solubilized in petrolatum, a non-aqueous gel that has fewer unwanted side effects than K-Y Warming Gel, had enhanced activity in the killing of both methicillin-sensitive and methicillin-resistant S. aureus . GML in petrolatum also killed two coagulase-negative staphylococci. Collectively, all staphylococci were killed by GML concentrations of ≥500 µg/mL. This concentration is 100 times below the concentration of GML we previously used in vivo in humans as solubilized in K-Y Warming Gel. GML in petrolatum also effectively killed four viridans streptococci, organisms increasingly recognized as pathogenic in atopic dermatitis in children. GML (50,000 µg/mL) in petrolatum was bactericidal for S. aureus as tested in a dermatitis model in rabbits. The data suggest that GML in petrolatum, upon additional testing, may become useful in topical management of nasal and skin colonization of children, as well as older individuals, with S. aureus and viridans streptococci, and for use in management of Gram-positive bacteria in atopic dermatitis and diabetic ulcers.IMPORTANCEMost staphylococcal and streptococcal infections in humans originate from mucous membranes, usually the anterior nares, or from the skin. Glycerol monolaurate (GML) solubilized in petrolatum exhibited potent anti-Gram-positive bacteria activity as tested both in vitro and in a staphylococcal rabbit skin model. Because GML is generally recognized as safe (GRAS by FDA) and petrolatum is already approved for topical human use, our data suggest that upon additional testing GML in petrolatum may be effective for topical use in management of nasal and skin colonization with S. aureus and viridans streptococci in young children (as well as older individuals), and for use in management of bacterial infections in atopic dermatitis and diabetic ulcers.
Microstructured silicone membrane as an ultra-microskin grafting cover: Transparent and promoting wound healing [PMID: 41825358 · 2026]
Ultra-microskin grafting shows promising prospects for the treatment of deep wounds. However, the survival rate of ultra-microskin and wound healing speed are significantly limited by the covering. This study developed a novel microstructured silicone membrane (MSM) as an optimal covering for ultra-microskin grafts. A MSM with small concave surface features was fabricated. The membrane's morphology was observed using scanning electron microscopy and laser electron microscopy. Water-vapor transmission rate (WVTR) and hydrophilicity/hydrophobicity were assessed. Cytotoxicity was evaluated using the CCK-8 method, and fibroblasts were seeded on the membrane to observe cell growth. An rat full-thickness skin defect model was used, and ultra-microskin grafts (0.4 mm×0.4 mm) were transplanted onto the wound at a 1:10 enlargement ratio. The wounds were covered with MSM, allograft skin (AS), or vaseline gauze (VG), and the wound healing rate and histological changes were compared. One side of the MSM is smooth and flat, while the other side is covered with micro convex-concave structures. The membrane is hydrophobic with a WVTR of 638.33 ± 37.50 g/(m²·24 h), similar to normal skin. In vitro toxicity tests showed no significant toxicity, and the cells were able to survive and grow on the membrane. In the rat model, the MSM group showed significantly faster wound healing (59.75 ± 0.87% closure at day 14, 90.10 ± 0.63% at day 21) than both the AS (17.90 ± 0.29% at day 21) and VG groups (28.53 ± 1.11% and 60.88 ± 0.71% at days 14 and 21, respectively; all p < 0.0001). Additionally, it promoted epithelialization, basement membrane formation, and collagen deposition in the dermis, while enhancing cell proliferation, neovascularization, and reducing inflammation at the wound site. The MSM is transparent, visually clear, and possesses excellent breathability, conformability, and biocompatibility. It provides an optimal moist microenvironment for ultra-microskin grafting and wound healing. The membrane attaches closely to the wound without significant adhesion, preventing graft displacement and clumping, while minimizing damage during dressing changes. This enhances graft survival and accelerates wound healing.
Effects of polymer oxygenated alginate dressings for healing skin graft donor areas: A phase III randomized controlled trial [PMID: 41713054 · 2026]
Oxygen-generating alginate plays an important therapeutic role in wound treatment. In several studies, oxygen-generating alginate synthetic dressings have been shown to promote wound healing. We conducted a multicenter, open-label, phase III randomized clinical trial of split-thickness skin graft donor site treatment. We recruited patients with a burn size of less than 30 % total body surface area (TBSA) who required skin grafting. Patients were randomized into two groups: one group received treatment with polymer oxygenated alginate (POA) dressing (n = 69), and the other group received conventional Vaseline gauze dressing (n = 70). All patients were followed up for a predefined period until the primary outcome was assessed. The primary end point was the wound healing time. A total of 141 adult patients underwent randomization and 137 completed the trial. Wounds healed faster in the POA group than in the Vaseline gauze group (P < 0.0001). At the first five visits, wound healing rates in the POA group were higher than those in the Vaseline gauze group (P < 0.01). Pain scores were lower ( P = 0.011), and the satisfaction scores were higher (P < 0.05) in the POA group. No significant differences in wound infections and inflammation were detected between the two groups. Two adverse events occurred, but neither was related to the study products or procedures. Our results demonstrate that POA dressing is safe and clinically effective for treating split-thickness skin graft donor site wounds. It may be effective in controlling wound infection and inflammation; however, further validation is required.
Contact Allergy to Topical Corticosteroids in Atopic Dermatitis: Diagnostic Gaps in Baseline Patch Testing [PMID: 42184978 · 2026]
Chronic exposure to topical corticosteroids (TCS) in patients with atopic dermatitis (AD) may increase the risk of allergic contact dermatitis (ACD), which can mimic flares of the underlying disease and remain underrecognized. To evaluate patterns of TCS sensitization in patients with AD compared with patients without AD, with particular emphasis on the diagnostic limitations of baseline patch testing and the effect of test vehicle on allergen detection. In this prospective study conducted between September 2023 and January 2024, 80 patients with AD and 80 patients without AD underwent patch testing. The corticosteroid markers included in the Polish Baseline Series were budesonide 0.01% pet. and tixocortol pivalate 0.1% pet. The extended corticosteroid panel additionally included clobetasol-17-propionate 1.0% pet. and hydrocortisone-17-butyrate 1.0%, tested in petrolatum (pet.) and ethanol (alc.). Patch test readings were performed at 48, 72 h, and Day 7. Sensitization to hydrocortisone-17-butyrate was significantly more frequent in patients with AD than in patients without AD (23.8% vs. 8.8%; p = 0.018; OR 3.25, 95% CI 1.28-8.25). Positive reactions occurred exclusively to hydrocortisone-17-butyrate 1.0% in ethanol, whereas hydrocortisone-17-butyrate 1.0% in petrolatum was negative in all tested subjects. No positive reactions were observed to budesonide or tixocortol pivalate. Sensitization to clobetasol-17-propionate was uncommon and observed only in adults. Most reactions were first clearly detectable at 72 h or increased in intensity between 48 and 72 h, and one paediatric patient with AD had a delayed positive reaction detectable only on Day 7. The Polish Baseline Series alone may fail to detect some potentially clinically relevant TCS sensitizations in selected patients with AD. Extended corticosteroid testing, attention to the test vehicle, and Day 7 readings may improve case detection in selected clinical scenarios, particularly in patients with persistent or apparently treatment-refractory AD.
Tapinarof as a Likely Contact Allergen: Evidence From Patch Testing of Allergic and Irritant Contact Dermatitis [PMID: 42184966 · 2026]
Tapinarof cream 1% is a novel, non-steroidal topical aryl hydrocarbon receptor-modulating agent approved for the treatment of plaque psoriasis and atopic dermatitis (AD). There has only been one report of allergic sensitization to tapinarof cream. This study aimed to determine whether tapinarof cream-induced contact dermatitis represents an allergic or irritant reaction, and to identify the causative allergen in allergic cases. Nine patients (seven with psoriasis and two with AD) who developed contact dermatitis during treatment with tapinarof cream were included. Patch testing was performed with the cream as is; tapinarof at concentrations of 1%, 0.3%, and 0.1% in petrolatum; and two additives (propylene glycol 10% aqueous solution and disodium edetate hydrate 1% in petrolatum). Patch testing with tapinarof cream as is was positive in four patients with psoriasis and both patients with AD. All six patients also showed dose-response relationships with tapinarof, increasing from 0.1% to 1%. The remaining three patients with psoriasis showed negative patch test results to both the cream as is and its individual components. Tapinarof cream-induced contact dermatitis may present as either an allergic or irritant reaction. In all six allergic cases, tapinarof was strongly suggested to be the causative allergen.
Evaluating Medicaid Coverage for Over-the-Counter Treatments for Diaper Dermatitis [PMID: 42116742 · 2026]
Diaper dermatitis is a common dermatologic condition in infancy, frequently managed with over-the-counter (OTC) products. We conducted a cross-sectional review of Medicaid Preferred Drug Lists across 49 states and the District of Columbia to evaluate coverage of 14 commonly used OTC diaper dermatitis treatments. Coverage varied widely by state and product class, with therapeutic agents, such as topical antifungals, low potency corticosteroids, and antibiotics, more frequently covered than preventive barrier products, such as petrolatum and zinc oxide. These findings reveal significant state-level disparities in Medicaid coverage and highlight the potential access gaps for low-income families managing a common pediatric condition.
Allergic Contact Dermatitis to 1,3-Diphenylguanidine Over a 23-Year Period: Recent Cases Involve Sterile Polyisoprene Gloves [PMID: 42099181 · 2026]
1,3-Diphenylguanidine (DPG) is a known contact sensitiser and rubber vulcaniser. A retrospective audit was performed including 2675 patients tested to 1% DPG in petrolatum between 2002 and 2024. The MOAHLFA index of those with allergic contact dermatitis (ACD) was compared to the remainder of the patch test clinic population. Temporal changes in the prevalence of contact allergy and ACD to DPG were assessed. 50 (1.9%) patients had positive reactions to DPG on patch testing, with 31 (62% of positive reactions) diagnosed with ACD. In those with ACD, there was a significantly higher proportion of men (64.5% vs. 30.6%, p < 0.001), more occupational cases (41.9% vs. 17.7%, p < 0.001), more cases with hand dermatitis (64.5% vs. 33.1%, p < 0.001), more cases aged over 40 years (71.0% vs. 53.2%, p = 0.048), and fewer cases with face dermatitis (9.7% vs. 25.5%, p = 0.043). The most common exposure sources were gloves and shoes, with the four most recent cases involving polyisoprene (PI) gloves. However, information regarding DPG in shoes was lacking, and some patients reacted to multiple haptens, making it unclear as to the primary culprit. DPG causes occupational ACD in especially in healthcare workers (HCW), with recent cases involving exposure to PI gloves.
Mixing povidone-iodine and erythromycin ointment in skin wound management: a reconsidered practice [PMID: 41905627 · 2026]
Concomitant Use of Dermo-Cosmetic Skin Care in Aesthetic Procedures: Systematic Review with Expert Panel Recommendations [PMID: 41773167 · 2026]
As demand for nonsurgical aesthetic procedures increases, interest is also growing for desirable skin quality-radiant, healthy, and glowing skin-by patients seeking treatment to improve appearance. Although aesthetic medicine physicians are well positioned to advise on the role of basic skin care products in maintenance of results and healing, clear guidelines and protocols are currently lacking regarding the standard use of these products before and after aesthetic procedures. An international panel of dermatologists (n = 6) and plastic surgeons (n = 2) convened virtually in March 2022 to discuss the role of skin care before and after nonsurgical aesthetic procedures (including injectables, energy-based devices, chemical peels, and microdermabrasion). As an outcome of that meeting, expert recommendations were developed for periprocedural skin care with the goal of improving recovery time or treatment outcomes for each procedure based on clinical evidence from a systematic literature review of relevant articles published through June 2022 combined with the authors' experience. Overall, 104 publications were identified and reviewed; publications could be counted more than once if they covered more than one topic (energy-based procedures, n = 70; injectable procedures including microneedling, n = 25; chemical peels, n = 21; microdermabrasion, n = 10). Common periprocedural skin care included daily routines utilizing cleansers, moisturizers, toners, hydroquinone, antioxidant serums, and sunscreens (as needed) across procedure types. Evidence supports pre/post-procedure routines (cleansers, moisturizers, toners, hydroquinone, antioxidants, sunscreens) across injectables (n = 25 studies), energy devices (n = 70), peels (n = 21), microdermabrasion (n = 10); high-evidence data limited, petrolatum/antioxidants show particular benefit post-laser. Panel consensus endorses tailored regimens to optimize recovery/outcomes. However, very few studies were designed to evaluate a specific routine vs no skin care treatment. Further studies are needed to provide clinical evidence supporting the effectiveness of periprocedural skin care in reducing healing time and improving aesthetic outcomes. Herein, we provide evidence- and expert-based recommendations for incorporating daily skincare, including cleansers, moisturizers, antioxidant serums, depigmenting agents, and sunscreens, into periprocedural care for minimally invasive aesthetic treatments. These regimens should be adapted to procedure type and individual post-procedural responses and symptoms to optimize outcomes and address specific patient needs.
Higher Prevalence of Contact Sensitization to Dodecyl Gallate in Patients With Atopic Dermatitis: A Cross-Sectional Study [PMID: 41766254 · 2026]
Background: Gallates are antioxidant preservatives widely used in cosmetics and foods, with dodecyl gallate considered the most allergenic derivative. Despite increasing exposure, it is not included in European baseline patch-test series, and its relevance in patients with atopic dermatitis (AD) remains poorly defined. Objectives: To determine the prevalence of contact sensitization to dodecyl gallate in patients with AD compared with nonatopic controls and to explore age- and severity-related differences. Methods: In this cross-sectional study, 160 consecutively tested patients were included: 80 with AD (Hanifin-Rajka criteria) and 80 nonatopic controls with allergic contact dermatitis. Patch testing followed International Contact Dermatitis Research Group guidelines. All patients were tested with the Polish Baseline Series, and dodecyl gallate 0.25% petrolatum was added as a single supplemental allergen. Reactions were read at 48 hours, 72 hours, and Day 7; + to +++ reactions at 72 hours were considered positive. Results: Sensitization to dodecyl gallate occurred in 16/80 patients with AD (20.0%) and 6/80 controls (7.5%) (odds ratio 3.08; 95% Confidence Interval (CI) 1.15-8.57; P = 0.037). Within the AD cohort, sensitization was detected in 10/36 adults (23.3%) and 6/44 children (13.6%), whereas among controls it was observed in 6/38 adults (15.8%) and 0/42 children. The difference was significant in children (13.6% vs 0%; P = 0.026) but not in adults (23.3% vs 15.8%; P = 0.264). No association was found between AD severity and sensitization ( P = 0.720). Most reactions were weakly positive; 3 ++ reactions occurred only in AD. Conclusions: Dodecyl gallate is a clinically relevant and likely underrecognized allergen, with a significantly higher prevalence of sensitization in patients with AD-driven primarily by the pediatric population. These findings support consideration of targeted testing for dodecyl gallate, particularly in children with AD and persistent eczematous dermatitis.
The Impact of Vehicle Occlusivity on Skin Delivery and Activity of a Janus Kinase Inhibitor: Comparison of Oil-Based Formulations [PMID: 41599117 · 2025]
Background/Objectives: Baricitinib, a selective JAK1/JAK2 inhibitor, shows therapeutic potential in psoriasis; however, its oral use is associated with systemic adverse effects, encouraging the development of topical formulations. This study aimed at evaluating the influence of petrolatum type on the stability, biopharmaceutical performance, and therapeutic activity of lipid-based formulations containing Baricitinib. Methods : Formulations were prepared with Labrafac ® Lipophile WL 1349 (L) and either liquid (LLV) or solid (LSV) petrolatum at 30% and 60% w / w . Stability, rheology, spreadability, in vitro release, ex vivo permeation, and skin retention were evaluated, along with the safety and efficacy in HET-CAM and imiquimod-induced psoriasis murine models. Results : Only 30% petrolatum formulations remained stable for 60 days. LLV exhibited Newtonian flow, higher spreadability, sustained release (83.7% at 50 h), and superior skin retention (94 µg/g of skin/cm 2 ), whereas LSV showed pseudoplastic behavior, lower spreadability, and reduced release (47.4% at 50 h). Both formulations were non-irritant and improved stratum corneum hydration while reducing transepidermal water loss. In vivo, both reduced erythema, epidermal thickening, edema, and histological alterations, confirming anti-inflammatory efficacy. Conclusions : These results demonstrate that the vehicle occlusivity decisively modulates baricitinib's release and activity. LLV formulation favored drug retention and enhanced permeation at 24 h. Overall, excipient selection is important in designing safe and effective topical JAK inhibitor formulations.
The Influence of Phyto-Active Incorporated Topical Formulations on Cell Migration in Scratch Assays and In vivo Wound Model in Mice [PMID: 41540520 · 2026]
Vitis vinifera L. seed oil, Trigonella foenum-graecum L. seed oil, and the Olea europaea L. oil macerates of Helichrysum italicum (Roth) G. flowers and Matricaria recutita L. flowers were used for the preparation of topical wound-healing ointments. The ointments basically were prepared by hot-melt blending method and subjected to rheological tests and texture profile analysis. After characterization of in vitro characterization studies, a scratch assay was conducted to evaluate the efficacy of ointment formulations. Ultimately, the optimized formulations underwent further testing on an in vivo burn wound model in mice. Measured viscosity values were F1:382.98 Pa.s and F2:2562.3 Pa.s, respectively, and both of the formulations created an easy-to-apply, soft, thin adhesive film layer. The fast wound closure was observed with F1 formulation, and when applied at different doses of 100 μL, 200 μL, and 400 μL, the 200 μL concentration of F1 formulation was able to heal the wound totally (100 %) at 48th hour. The F1 formulation presented lower viscosity than the F2; the increase in the white petrolatum concentration increased the initial viscosity as expected. F1 formulation had higher phyto-actives and cera alba and lower petrolatum in comparison to F2. The wound healing effects of both the formulations were synergistic due to their phytoactives content. In in vivo studies, the F1 ointment exhibited faster re-epithelialization with less inflammation compared to the burn control group. The best formulation included oils of H. italicum, M. recutita, V. vinifera, and T. foenum-graecum at a total concentration of 16%, exhibiting appropriate preadability and successful healing property. Additional research needs to be carried out to shed light on the mechanism underlying the formulation's healing capabilities.
Frequently Asked Questions (AEO Position 0)
- Q1. What are the official 7-track regulatory label names for PETROLATUM?
- Standard label names are US PCPC INCI: 'PETROLATUM', EU CosIng: 'PETROLATUM', KR MFDS: 'PETROLATUM (KR MFDS Registered)', CN NMPA IECIC: '矿脂', and JP JCIA: 'ワセリン'.
- Q2. Is PETROLATUM restricted or permitted in EU, US, KR, CN, and JP cosmetics?
- Regulatory status summary across 6 jurisdictions — KR: noted, EU: banned, US: none, CN: noted, JP: none, ASEAN: none.
- Q3. What is the typical formulation concentration and optimal pH window for PETROLATUM?
- In emulsion_cream systems, PETROLATUM is typically formulated between 2% and 18% (median 4.55%), with an optimal stability window of pH 4–8.
- Q4. What are the known formulation incompatibilities and synergy pairings for PETROLATUM?
- Recommended synergy pairings include GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL. Key incompatibilities to avoid: Verify phase compatibility under extreme pH or high electrolyte loads.