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 | |
| Medline Industries, LP | 53329-919 | TOPICAL | 0.13 g in 100 g | 9/9/2025 | |
| EcoRhine LLC | 85577-002 | TOPICAL | 0.12 mg in 100 mg | 6/29/2025 | |
| CVS | 69842-642 | ORAL | 0.13 g in 100 g | 8/12/2025 | |
| Horizon Tool Inc. | 74683-6300 | TOPICAL | 0.13 mg in 100 mL | 5/1/2025 | |
| Navajo Manufacturing Company Inc. | 67751-237 | TOPICAL | 0.13 g in 100 g | 7/17/2025 | |
| VERITIV OPERATING COMPANY | 71897-224 | TOPICAL | 1.3 mg in 1 mL | 8/1/2025 | |
| Tazza Brands East, Inc. | 76370-0016 | TOPICAL | 0.13 g in 100 mL | 8/13/2025 | |
| ECOLAB Food Safety and Specialties, Inc. | 71338-122 | TOPICAL | 1.3 g in 1 L | 9/9/2025 |
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 |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
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 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| SMART HANDS | ostrem chemical co ltd. | 02515725 | Solution - Topical (Commercial) | 0.1 % / W/W | N/A |
| ANTISEPTIC SWABS 4MG/ML | zee medical | 00873381 | Pad - Topical | 4 MG / ML | 12/31/1990 |
| ANTISEPTIC HAND GEL | amakris products, inc. | 02292742 | Gel - Topical (Household) | 0.15 % | 4/5/2010 |
| THUROCLENS ANTIMICROBIAL CATIONIC CLEANSER | woodward laboratories, inc. | 02240869 | Liquid - Topical | 0.13 MG / 100 MG | 9/4/1999 |
| HOME HAND SANITIZER | home hardware stores limited | 02498170 | Solution - Topical | 0.13 % / W/W | 4/30/2020 |
| FOAMING ANTISEPTIC HAND SANITIZER | quality contract manufacturing | 02339994 | Liquid - Topical (Household) | 0.1 % / W/W | N/A |
| GMS HPG HAND SANITIZER | gms surface tech limited | 02426102 | Gel - Topical | 0.1 % / W/V | N/A |
| FOAMING HAND SANITIZER | 02312603 | Liquid - Topical | 0.1 % / W/W | N/A | |
| WISH BENZALKONIUM CHLORIDE HAND WIPES | b 2 fashions inc. | 02512580 | Wipe - Topical (Household) | 0.13 % / V/V | N/A |
| EZ PUR HAND SANITIZER FOR KIDS | prelam enterprises limited | 02512378 | Spray - Topical (Household) | 0.15 % / W/W | 4/5/2021 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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