# ALLANTOIN (allantoin) — Global Cosmetic Regulatory & Formulation Monograph

- **Canonical URL**: https://www.inciname.com/en/ingredients/allantoin
- **Standard INCI**: `ALLANTOIN`
- **KR MFDS Standard Name**: `알란토인`
- **CAS No.**: `97-59-6`
- **EC / EINECS No.**: `202-592-8`
- **Origin**: `synthetic`
- **Functions**: 피부컨디셔닝제, 피부보호제, 진정제
- **Molecular Formula / MW**: `C4H6N4O3` (158.12 g/mol)

## 1. 7-Track Official Regulatory Label Names
| Track | Official Label Nomenclature |
| :--- | :--- |
| KR (MFDS Standard) | 알란토인 |
| KR (Former Names) | — |
| EU (CosIng 1223/2009) | ALLANTOIN |
| US (PCPC / MoCRA INCI) | ALLANTOIN |
| US (FDA OTC Monograph) | ALLANTOIN |
| CN (NMPA IECIC) | 尿囊素 |
| JP (JCIA / MHLW QD) | アラントイン (QD: アラントイン) |

## 2. Layer 1 — Global 6-Region Statutory Summary
- **KR (MFDS)**: `none`
- **EU (1223/2009)**: `none`
- **US (FDA/MoCRA)**: `restricted`
- **CN (NMPA IECIC)**: `allowed` (Entry: `4823`)
- **JP (MHLW)**: `restricted`
- **ASEAN (ACD)**: `none`

- **JP** [limited]: ≤ 0.3% —  (化粧品に配合可能な医薬品の成分について(薬食審査発第0524001号) 별첨 「承認化粧品成分の範囲」)
- **US** [restricted]: 0.5~2% — US FDA OTC Skin Protectant Monograph (21 CFR 347.10): Permitted as OTC Skin Protectant Active at 0.5% to 2.0%. (21 CFR Part 347 (OTC Skin Protectant Monograph))

## 3. Layer 2 — Toxicological & Historical Safe Use Concentrations
- **cn_iecic_max** (leave_on): ≤ 2% — NMPA IECIC (2025) Entry 04850 (2025)
- **cn_iecic_max** (rinse_off): ≤ 2% — NMPA IECIC (2025) Entry 04850 (2025)

## 4. Layer 3 — Formulation Quartiles & Compatibility
- **Optimal pH Window**: 4 – 7.5
- **Max Process Temp**: ≤ 70°C
- **Synergy Pairings**: PANTHENOL, BETAINE, DIPOTASSIUM GLYCYRRHIZATE, MADECASSOSIDE
- **Incompatibilities**: CRITICAL RECRYSTALLIZATION HAZARD: Water solubility drops from ~0.5% at 25°C to ~0.30% at 4°C! Incorporating >0.35% in clear aqueous toners/serums causes sharp, glass-like needle crystals to precipitate during cold storage, scratching skin! Limit to 0.1~0.3% in aqueous solutions or co-solubilize with Betaine; Decomposes into Urea if heated > 75°C for prolonged periods or at pH > 8.0

## 5. Academic Monograph
■ [1. Chemical Identity & International Labeling Nomenclature]
  - INCI Name: ALLANTOIN | CAS No.: 97-59-6 | EC No.: 202-592-8
  - Origin: SYNTHETIC | Functions: Skin Conditioning, , 
  - Physicochemical Profile: Formula C4H6N4O3 | MW 158.12 g/mol | LogP -2.26 | Ionic Nature: amphoteric | PubChem CID 204
  - Official Regional Label Names: US [ALLANTOIN] · EU [ALLANTOIN] · CN [尿囊素] · JP [アラントイン] · JP Quasi-Drug [アラントイン]
■ [2. Dermatological Mechanism of Action & Functional Role]
  - Heterocyclic diureide of glyoxylic acid recognized under the US FDA OTC Skin Protectant Monograph (0.5~2.0%). Enhances corneocyte water-binding capacity, promotes gentle keratolytic softening of scaly skin, and accelerates epithelial wound healing and soothing.
■ [3. Global 6-Jurisdiction Regulatory Status & Safety Limits (Layer 1 & Layer 2)]
  - Regional Summary: KR: NONE | EU: NONE | US: RESTRICTED | CN: ALLOWED | JP: RESTRICTED | ASEAN: NONE (CN IECIC (2025) Entry No. 4823 (尿囊素))
  - [JP / COMPOSITION / limited] (Max 0.3%): 
  - [US / OFFICIAL / restricted] (Max 2.0%): US FDA OTC Skin Protectant Monograph (21 CFR 347.10): Permitted as OTC Skin Protectant Active at 0.5% to 2.0%.
  - Official Safety & Historical Use Concentration (Layer 2): CN_IECIC_2025 (cn_iecic_max, leave_on): Max 2.0% / CN_IECIC_2025 (cn_iecic_max, rinse_off): Max 2.0%
■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)]
  - [aqueous_serum] Typical range: 0.1 ~ 0.35% (Median 0.2%, Ref: CIR Allantoin Safety Assessment & US FDA OTC Skin Protectant Monograph) — Soothing keratolytic & skin protectant (Strictly ≤ 0.35% in clear aqueous serums to prevent 4°C crystal precipitation)
  - [emulsion_cream] Typical range: 0.1 ~ 2.0% (Median 0.3%, Ref: US 21 CFR 347.10 & CIR Allantoin Assessment) — Soothing barrier cream & US FDA OTC Skin Protectant active (0.5~2.0%)
■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)]
  - Addition Phase: Warm Water Phase (50~65°C; Do not exceed 75°C or pH > 8.0)
  - Optimal pH Range: pH 4.0 ~ 7.5 | Max Process Temp: Max 70°C | Electrolyte Tolerance: HIGH
  - Incompatibility / Caution: CRITICAL RECRYSTALLIZATION HAZARD: Water solubility drops from ~0.5% at 25°C to ~0.30% at 4°C! Incorporating >0.35% in clear aqueous toners/serums causes sharp, glass-like needle crystals to precipitate during cold storage, scratching skin! Limit to 0.1~0.3% in aqueous solutions or co-solubilize with Betaine
  - Incompatibility / Caution: Decomposes into Urea if heated > 75°C for prolonged periods or at pH > 8.0
  - Synergy Pairings: PANTHENOL, BETAINE, DIPOTASSIUM GLYCYRRHIZATE, MADECASSOSIDE | Reference Trade Names: Allantoin USP/EP
■ [6. Peer-Reviewed Literature & Official Compendia Evidence]
  - PMID 20448269 (2010, Int J Toxicol): Final report of the safety assessment of allantoin and its related complexes
  - PMID 40177799 (2025, J Cosmet Dermatol): Efficacy and Safety of Topical Compound Heparin Sodium Allantoin Gel (Main Components: Onion Extract Quercetin) for the 
  - PMID 33811776 (2022, J Cosmet Dermatol): A randomized controlled trial to compare the effectiveness and safety of adsorbent lotion containing tapioca starch, spe

## 6. Linked PubMed Literature
- [PMID: 20448269] Final report of the safety assessment of allantoin and its related complexes — *Int J Toxicol* (2010)
- [PMID: 40177799] Efficacy and Safety of Topical Compound Heparin Sodium Allantoin Gel (Main Components: Onion Extract Quercetin) for the Treatment of Rosacea — *J Cosmet Dermatol* (2025)
- [PMID: 33811776] A randomized controlled trial to compare the effectiveness and safety of adsorbent lotion containing tapioca starch, spent grain wax, Butyrospermum parkii extract, argania spinosa kernel oil, aloe barbadensis, rosehip oil, and allantoin with a low-potency topical corticosteroid in the treatment of intertrigo — *J Cosmet Dermatol* (2022)
- [PMID: 22849762] A double-blind randomised controlled trial of a natural oil-based emulsion (Moogoo Udder Cream®) containing allantoin versus aqueous cream for managing radiation-induced skin reactions in patients with cancer — *Radiat Oncol* (2012)
- [PMID: 32576219] Efficacy and tolerability of the investigational topical cream SD-101 (6% allantoin) in patients with epidermolysis bullosa: a phase 3, randomized, double-blind, vehicle-controlled trial (ESSENCE study) — *Orphanet J Rare Dis* (2020)
- [PMID: 16875470] Use of onion extract, heparin, allantoin gel in prevention of scarring in chinese patients having laser removal of tattoos: a prospective randomized controlled trial — *Dermatol Surg* (2006)
- [PMID: 42190768] Photothermally enhanced drug release and anti-inflammatory effects of allantoin-loaded chitosan-based biomaterials incorporating melanin for transdermal drug delivery — *Int J Biol Macromol* (2026)
- [PMID: 41900878] Gelatin/Ascorbic Acid Scaffolds for Controlled Release of Allantoin: A Fully Natural Approach for Skin Tissue Regeneration Through Pro-Regenerative, Antimicrobial, and Keratinocyte-Supportive Properties — *Pharmaceutics* (2026)
- [PMID: 41771956] "Short-term effects of a single kangaroo mother care session on urinary allantoin and maternal-infant bonding in preterm neonates: a quasi-randomized controlled trial" — *Sci Rep* (2026)
- [PMID: 41471121] Thermosensitive Sprayable Lidocaine-Allantoin Hydrogel: Optimization and In Vitro Evaluation for Wound Healing — *Pharmaceutics* (2025)
- [PMID: 41122587] Synergistic Effects of the ThriveCo Bumps Eraser Kit: Exfoliating Scrub and Lotion in Reducing Skin Bumps and Enhancing Hydration With Spirulina, Alpha-Hydroxy Acid, Madhuca indica Oil, Allantoin, and Hydroxyethyl Urea — *Cureus* (2025)
- [PMID: 41911581] Allantoin Enhances Proliferation, Wound Closure, and Nrf2-Associated Antioxidant Defense in Mouse Embryonic Palatal Mesenchymal Cells:A Dose-Response Study — *J Craniofac Surg* (2026)
- [PMID: 42075837] Bioactive-Enriched Chitosan/Poly(vinyl Alcohol) Electrospun Nanofibers for Wound Healing: In Vitro and In Vivo Evaluation — *Pharmaceuticals (Basel)* (2026)
- [PMID: 41993578] Ethnopharmacological insights into Symphytum officinale L.: traditional uses, phytochemical composition, therapeutic potential, and clinical-toxicological implications — *Front Pharmacol* (2026)
- [PMID: 41772988] Understanding the efficacy and tolerability of topical therapies for epidermolysis bullosa — *Expert Rev Clin Pharmacol* (2026)
- [PMID: 41360560] Snail as a multifunctional biological resource: Nutritional value and pharmacological applications — *Food Res Int* (2026)
- [PMID: 41139126] Bio-Based Microfluidics With Snail Slime: A By-Product of Agriculture Plays an Exciting Role in the Chemistry of Microfluidic Reaction Chambers — *Macromol Rapid Commun* (2025)
- [PMID: 41068880] In vitro effect of Mikania cordata leaf extracts on wound healing — *BMC Complement Med Ther* (2025)