# TRANEXAMIC ACID (tranexamic-acid) — Global Cosmetic Regulatory & Formulation Monograph - **Canonical URL**: https://www.inciname.com/en/ingredients/tranexamic-acid - **Standard INCI**: `TRANEXAMIC ACID` - **KR MFDS Standard Name**: `트라넥사믹애씨드` - **CAS No.**: `1197-18-8` - **EC / EINECS No.**: `214-818-2` - **Origin**: `synthetic` - **Functions**: 수렴제, 피부컨디셔닝제 - **Molecular Formula / MW**: `C8H15NO2` (157.21 g/mol) ## 1. 7-Track Official Regulatory Label Names | Track | Official Label Nomenclature | | :--- | :--- | | KR (MFDS Standard) | 트라넥사믹애씨드 | | KR (Former Names) | — | | EU (CosIng 1223/2009) | TRANEXAMIC ACID | | US (PCPC / MoCRA INCI) | TRANEXAMIC ACID | | US (FDA OTC Monograph) | — | | CN (NMPA IECIC) | 凝血酸 | | JP (JCIA / MHLW QD) | トラネキサム酸 (QD: トラネキサム酸) | ## 2. Layer 1 — Global 6-Region Statutory Summary - **KR (MFDS)**: `none` - **EU (1223/2009)**: `none` - **US (FDA/MoCRA)**: `none` - **CN (NMPA IECIC)**: `allowed` (Entry: `4866`) - **JP (MHLW)**: `none` - **ASEAN (ACD)**: `none` ## 3. Layer 2 — Toxicological & Historical Safe Use Concentrations - **cn_iecic_max** (leave_on): ≤ 3% — NMPA IECIC (2025) Entry 04855 (2025) - **cn_iecic_max** (rinse_off): ≤ 3% — NMPA IECIC (2025) Entry 04855 (2025) ## 4. Layer 3 — Formulation Quartiles & Compatibility - **Optimal pH Window**: 5.5 – 7 - **Max Process Temp**: ≤ 65°C - **Synergy Pairings**: NIACINAMIDE, ALPHA-ARBUTIN, 3-O-ETHYL ASCORBIC ACID, KOJIC ACID, GLUTATHIONE - **Incompatibilities**: High zwitterionic strength immediately collapses standard Carbomer and Aristoflex AVC gels; formulate with SEPIMAX ZEN + Xanthan Gum or HEC; Ensure sufficient free water (>65%) at ≥3% dosage to prevent low-temperature recrystallization ## 5. Academic Monograph ■ [1. Chemical Identity & International Labeling Nomenclature] - INCI Name: TRANEXAMIC ACID | CAS No.: 1197-18-8 | EC No.: 214-818-2 - Origin: SYNTHETIC | Functions: , - Physicochemical Profile: Formula C8H15NO2 | MW 157.21 g/mol | LogP -1.6 | Ionic Nature: amphoteric | PubChem CID 5526 - Official Regional Label Names: US [TRANEXAMIC ACID] · EU [TRANEXAMIC ACID] · CN [凝血酸] · JP [トラネキサム酸] · JP Quasi-Drug [トラネキサム酸] ■ [2. Dermatological Mechanism of Action & Functional Role] - Synthetic lysine analogue that inhibits the keratinocyte urokinase-type plasminogen activator (uPA)/plasmin pathway. Blocks UV-induced release of arachidonic acid, prostaglandins (PGE2), and alpha-MSH, simultaneously targeting epidermal hyperpigmentation and dermal vascular erythema in melasma. ■ [3. Global 6-Jurisdiction Regulatory Status & Safety Limits (Layer 1 & Layer 2)] - Regional Summary: KR: NONE | EU: NONE | US: NONE | CN: ALLOWED | JP: NONE | ASEAN: NONE (CN IECIC (2025) Entry No. 4866 (凝血酸)) - No specific Annex prohibition or numeric restriction across the 6 major jurisdictions (Permitted under general GMP safety assessment). - Official Safety & Historical Use Concentration (Layer 2): CN_IECIC_2025 (cn_iecic_max, leave_on): Max 3.0% / CN_IECIC_2025 (cn_iecic_max, rinse_off): Max 3.0% ■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)] - [aqueous_serum] Typical range: 1.0 ~ 5.0% (Median 3.0%, Ref: PubMed Topical Tranexamic Acid Melasma RCTs & CN IECIC) — Plasminogen/keratinocyte-melanocyte paracrine signaling inhibitor for melasma & PIH - [emulsion_cream] Typical range: 1.0 ~ 5.0% (Median 3.0%, Ref: JP MHLW Quasi-Drug Standard & PubMed Clinical Trials) — Melasma & hyperpigmentation brightening cream active ■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)] - Addition Phase: Water Phase (< 60°C) - Optimal pH Range: pH 5.5 ~ 7.0 | Max Process Temp: Max 65°C | Electrolyte Tolerance: NONE - Incompatibility / Caution: High zwitterionic strength immediately collapses standard Carbomer and Aristoflex AVC gels; formulate with SEPIMAX ZEN + Xanthan Gum or HEC - Incompatibility / Caution: Ensure sufficient free water (>65%) at ≥3% dosage to prevent low-temperature recrystallization - Synergy Pairings: NIACINAMIDE, ALPHA-ARBUTIN, 3-O-ETHYL ASCORBIC ACID, KOJIC ACID, GLUTATHIONE | Reference Trade Names: Transamin™ Cosmetic Grade ■ [6. Peer-Reviewed Literature & Official Compendia Evidence] - PMID 42298161 (2026, Aesthetic Plast Surg): The Effects of Tranexamic Acid Injections on Surgical Scars: A Retrospective Study. - PMID 42294152 (2026, ACS Omega): Polyfunctional Ligand of the Clinical Setting: Thermodynamic Studies of the Equilibria of Tranexamic Acid in Aqueous Sol - PMID 42298166 (2026, Aesthetic Plast Surg): Effect of Tranexamic Acid to Reduce Postoperative Hematoma in Reduction Mammaplasty: A Retrospective Analysis of 656 Pat ## 6. Linked PubMed Literature - [PMID: 42298161] The Effects of Tranexamic Acid Injections on Surgical Scars: A Retrospective Study. — *Aesthetic Plast Surg* (2026) - [PMID: 42294152] Polyfunctional Ligand of the Clinical Setting: Thermodynamic Studies of the Equilibria of Tranexamic Acid in Aqueous Solutions. — *ACS Omega* (2026) - [PMID: 42298166] Effect of Tranexamic Acid to Reduce Postoperative Hematoma in Reduction Mammaplasty: A Retrospective Analysis of 656 Patients — *Aesthetic Plast Surg* (2026) - [PMID: 42293393] Tetrahedral framework nucleic acids carrying tranexamic acid to alleviate ultraviolet B-induced skin pigmentation — *Mater Today Bio* (2026) - [PMID: 42285569] Randomised, double-blind clinical trial protocol to evaluate whether early and perioperative tranexamic acid administration reduces transfusion rates and blood loss of patients undergoing hip fracture surgery in Spain — *BMJ Open* (2026) - [PMID: 42234395] Practical Therapeutic Strategies for Acne-Induced Hyperpigmentation Across all Skin Types — *Am J Clin Dermatol* (2026) - [PMID: 25422661] Topical tranexamic acid as a promising treatment for melasma. — *Journal of Research in Medical Sciences* (2014) - [PMID: 42297643] A meta-analysis on the efficacy of topical tranexamic acid for epistaxis: Does the method of administration affect the success rate? — *Australas Emerg Care* (2026) - [PMID: 42255827] Preoperative Local Infiltration of Tranexamic Acid in Posterior Lumbar Fusion: A Prospective Controlled Study — *Cureus* (2026) - [PMID: 42254037] Perioperative tranexamic acid in abdominally based free-flap breast reconstruction: A single-surgeon retrospective series — *JPRAS Open* (2026) - [PMID: 23829999] Tranexamic acid: A new treatment option for melasma — *Journal of Cosmetic Dermatology* (2013) - [PMID: 25422654] Topical tranexamic acid as a promising treatment for melasma — *Journal of Research in Medical Sciences* (2014) - [PMID: ] PubChem Compound Summary: Tranexamic Acid — *PubChem Compound Database* (2026)