Overview
Benzalkonium is a quaternary ammonium compound used as a biocide, a cationic surfactant, and as a phase transfer agent . Benzalkonium is more commonly contained in consumer products in its salt form, benzalkonium chloride . This salt is used in a great variety of international pharmaceutical products such as eye, ear, and nasal drops or sprays as an excipient ingredient serving as an antimicrobial preservative . When used as an ingredient in antiseptic and disinfectant products however, it is an active antimicrobial agent .
Indication
When used as an active ingredient in products like antibacterial, antiseptic, or disinfectant soaps, topical sanitizers, or cleaning agents, benzalkonium is primarily implemented in its salt form, benzalkonium chloride, where it may often be the only active ingredient present and indicated for the primary purpose of topical washing to decrease bacteria on skin . Conversely, when implemented as an excipient ingredient in a variety of multidose aqueous nose, eye, or ear products, benzalkonium chloride is being used as the antimicrobial preservative of choice to facilitate effective bactericidal and fungicidal actions to help minimize the growth of unwanted organisms in the multidose containers .
Associated Conditions
- Diaper Dermatitis
- Dry Eye Syndrome (DES)
- Eye and eyelid infections
- Gingivitis
- Haemorrhoids
- Infantile Eczema
- Mouth irritation
- Pruritus Ani
- Tonsillitis
- Throat inflammation
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/07/06 | Phase 2 | Completed | Turn Therapeutics | ||
2018/09/27 | Phase 4 | Completed | |||
2017/10/27 | Phase 4 | Completed | |||
2017/04/07 | Phase 4 | Completed | |||
2017/04/05 | Phase 4 | Completed | |||
2015/11/03 | Phase 4 | UNKNOWN | |||
2014/10/21 | Phase 4 | UNKNOWN | |||
2013/01/08 | Not Applicable | Completed | |||
2006/12/22 | Phase 1 | UNKNOWN | University of Rostock |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Carts and Parts INC. | 82402-010 | TOPICAL | 0.0019 g in 1 1 | 6/18/2025 | |
| ABC Compounding Co., Inc. | 62257-265 | TOPICAL | 25 mg in 1 mL | 4/22/2025 | |
| EcoRhine LLC | 85577-002 | TOPICAL | 0.12 mg in 100 mg | 6/29/2025 | |
| Horizon Tool Inc. | 74683-6300 | TOPICAL | 0.13 mg in 100 mL | 5/1/2025 | |
| Guangzhou Baihua Co., Ltd | 77665-001 | TOPICAL | 12 mg in 100 mg | 4/28/2025 | |
| Zep Inc. | 66949-105 | TOPICAL | 0.13 g in 100 mL | 5/15/2025 | |
| Meijer, Inc. | 79481-0135 | TOPICAL | 0.13 g in 100 mL | 12/5/2024 | |
| Ben E. Keith Foods | 50980-207 | TOPICAL | 1.3 mg in 1 mL | 3/3/2025 | |
| Kenvue Brands LLC | 69968-0730 | TOPICAL | 1.3 mg in 1 mL | 5/26/2025 | |
| Babikian Healthcare Products CJSC | 83640-402 | TOPICAL | 0.2 mg in 100 mL | 4/29/2025 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| QV FLARE UP BATH OIL | SIN11468P | LOTION | 6% w/w | 3/19/2001 | |
| DORITHRICIN THROAT LOZENGES | SIN04392P | LOZENGE | 1.0 mg | 5/3/1990 | |
| ORA-SED JEL | SIN04948P | GEL | 0.1 mg/ml | 7/16/1990 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Benzalkonium Chloride Patches | 国药准字H10920011 | 化学药品 | 贴剂 | 11/20/2019 | |
| Benzalkonium Chloride Solution | 国药准字H20193051 | 化学药品 | 溶液剂 | 12/25/2023 | |
| Benzalkonium Chloride Solution | 国药准字H20093305 | 化学药品 | 溶液剂 | 4/9/2024 | |
| Benzalkonium Chloride Solution | 国药准字H20063993 | 化学药品 | 外用溶液剂 | 5/15/2020 | |
| Benzalkonium Chloride Solution | 国药准字H20093306 | 化学药品 | 溶液剂 | 4/9/2024 | |
| Benzalkonium Chloride Solution | 国药准字H20183002 | 化学药品 | 洗剂 | 9/29/2022 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| ORIS-GEL | N/A | N/A | N/A | 9/20/1988 | |
| FUNGISKIN CREAM | N/A | N/A | N/A | 7/30/1982 | |
| DEQUASIN EXTRA LOZ - LEMON AND HONEY (HEXYLRESORCINOL & BENZALKONIUM CHLORIDE) | N/A | N/A | N/A | 7/20/2009 | |
| DEQUASIN EXTRA LOZ - BLACKBERRY (HEXYLRESORCINOL & BENZALKONIUM CHLORIDE) | N/A | N/A | N/A | 7/20/2009 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| Paxyl Spray aerosol | 29636 | Medicine | A | 10/25/1991 | |
| NYAL MOUTH ULCER GEL tube | 16132 | Medicine | A | 10/3/1991 | |
| NATURAL LOOK ANTISEPTIC CARE LOTION benzalkonium chloride 1.3 mg/mL lotion bottle | 45901 | Medicine | A | 7/30/1993 | |
| ADNOHR EAR CARE ANTISEPTIC | 13407 | Medicine | A | 8/21/1991 | |
| VIRASOLVE COLD SORE CREAM tube | 14500 | Medicine | A | 9/20/1991 | |
| DETTOL ANTISEPTIC WOUND WASH SPRAY benzalkonium chloride 1.98mg/mL bottle | 73357 | Medicine | A | 3/22/2000 | |
| BEPANTHEN ANTISEPTIC CREAM (reformulation 2) benzalkonium chloride 500 mcg/g tube | 182923 | Medicine | A | 5/6/2011 | |
| ADNOHR EAR CARE ANTISEPTIC | 13408 | Medicine | A | 8/21/1991 | |
| MEDISEPT ANTISEPTIC SPRAY WITH TEA TREE OIL FRAGRANCE | 61122 | Medicine | A | 9/15/1997 | |
| ROSSAN ANTISEPTIC EAR-CARE LOTION SPRAY benzalkonium chloride 0.13% w/w spray, solution bottle | 199509 | Medicine | A | 7/24/2012 |
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