Overview
Chlorhexidine is a broad-spectrum antimicrobial biguanide used as a topical antiseptic and in dental practice for the treatment of inflammatory dental conditions caused by microorganisms. It is one of the most common skin and mucous membrane antiseptic agents in use today. The molecule itself is a cationic bis-guanide consisting of two 4-chlorophenyl rings and two biguanide groups joined by a central hexamethylene chain. Topical chlorhexidine for disinfection, as well as oral rinses for dental use, carries activity against a broad range of pathogens including bacteria, yeasts, and viruses. Chlorhexidine was developed in the UK by Imperial Chemical Industries in the early 1950s and was introduced to the US in the 1970s. The FDA withdrew its approval for the use of chlorhexidine gluconate topical tincture 0.5%, due to a significant number of reports concerning chemical and thermal burns associated with the use of this product. Other formulations of chlorhexidine continue to be available.
Indication
Chlorhexidine is available over-the-counter in various formulations (e.g. solution, sponge, cloth, swab) as a topical antiseptic to sanitize prior to surgeries and/or medical procedures. Dental formulations, available by prescription only, include an oral rinse indicated for the treatment of gingivitis and a slow-release "chip" which is inserted into periodontal pockets and is indicated for the reduction of pocket depth in adult patients with periodontitis as an adjunct therapy to dental scaling and root planing procedures.
Associated Conditions
- Aphthous ulcer
- Catarrh of the throat
- Chemotherapy Induced Oral Mucositis
- Chronic Wounds
- Decubitus Ulcer
- Dental Cavity
- Dysphagia
- Eczema infected
- Foeter Ex Ore
- Gingival Bleeding
- Gingival Diseases
- Gingivitis
- Glossitis
- Hoarseness
- Infection
- Infectious Periodontal Diseases
- Injury Throat
- Mild to Moderate Inflammatory Reaction of the Oral Cavity
- Mild to Moderate Inflammatory Reaction of the Pharynx
- Mouth injury
- Mucositis
- Neurodermatitis
- Ocular Inflammation
- Ocular Irritation
- Oral Aphthous Ulcer
- Pain
- Periodontitis
- Pharyngitis
- Plaque, Dental
- Postoperative Wound Infection
- Purulent Gingivitis
- Radiation Mucositis
- Red eye
- Ringworm
- Skin Infections
- Sore Throat
- Stomatitis
- Surgical Wounds
- Tissue Damage
- Tonsillitis
- Ulcers, Leg
- Wound Infections
- Bacterial skin infections
- Dry, cracked skin
- Gum pain
- Moderate Gingivitis
- Oral infections
- Oral lesions
- Recurrent Oral fungal infection
- Severe Gingivitis
- Superficial Wounds
- Throat disinfection
- Tongue inflammation
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/10 | Not Applicable | Not yet recruiting | |||
2025/07/03 | Not Applicable | ENROLLING_BY_INVITATION | |||
2025/04/20 | Not Applicable | Completed | Federal Teaching Hospital Abakaliki | ||
2025/02/19 | Not Applicable | Completed | |||
2025/02/06 | Phase 1 | Completed | Armed Forces Institute of Dentistry, Pakistan | ||
2025/01/15 | Phase 1 | Completed | Krishnadevaraya College of Dental Sciences & Hospital | ||
2024/12/13 | Phase 3 | Recruiting | |||
2024/12/13 | Not Applicable | Active, not recruiting | MELEK UNLUGEDIK | ||
2024/12/13 | Phase 4 | Completed | Gabriel John Culbert | ||
2024/12/02 | Phase 2 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Proficient Rx LP | 63187-524 | ORAL | 1.2 mg in 1 mL | 1/1/2021 | |
| Natco Pharma USA LLC | 69339-138 | ORAL | 1.2 mg in 1 mL | 10/30/2023 | |
| Lyne Laboratories, Inc. | 0374-5080 | ORAL | 1.2 mg in 1 mL | 1/2/2019 | |
| Lohxa | 70166-027 | ORAL | 1.2 mg in 1 mL | 2/25/2021 | |
| Xttrium Laboratories, Inc. | 0116-1061 | TOPICAL | 4 g in 100 mL | 4/30/2025 | |
| ATLANTIC BIOLOGICALS CORP. | 17856-0272 | BUCCAL | 1.2 mg in 1 mL | 3/1/2022 | |
| Henry Schein, Inc. | 0404-0178 | DENTAL | 1.2 mg in 1 mL | 2/28/2023 | |
| Rising Pharma Holdings, Inc. | 16571-128 | DENTAL | 1.2 mg in 1 mL | 8/28/2023 | |
| Major Pharmaceuticals | 0904-7035 | ORAL | 1.2 mg in 1 mL | 11/23/2022 | |
| VistaPharm, LLC | 66689-106 | BUCCAL | 1.2 mg in 1 mL | 2/8/2024 |
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 |
|---|---|---|---|---|---|
| HORF LOZENGES | SIN08535P | LOZENGE | 5 mg | 2/5/1996 | |
| SILVIN CREAM | SIN10131P | CREAM | 0.2% w/v | 10/2/1998 | |
| PerioChip | SIN13278P | LINER, DENTAL | 2.50 mg | 5/21/2007 | |
| ORAL AID LOTION | SIN04696P | LOTION | 0.5% w/v | 6/13/1990 | |
| SOOV CREAM | SIN08901P | CREAM | 0.2% w/w | 9/4/1996 | |
| DIFFLAM-C ANTI-INFLAMMATORY ANTISEPTIC SOLUTION | SIN08671P | MOUTHWASH | 18 mg/15 ml | 4/24/1996 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Dilute Chlorhexidine Gluconate Solution | 国药准字H21023991 | 化学药品 | 溶液剂 | 5/12/2020 | |
| Chlorhexidine Acetate Ointment | 国药准字H11021492 | 化学药品 | 软膏剂 | 1/29/2021 | |
| Chlorhexidine Acetate Powder | 国药准字H13024259 | 化学药品 | 散剂 | 10/12/2020 | |
| Chlorhexidine Gluconate Solution | 国药准字H20064352 | 化学药品 | 原料药 | 3/2/2021 | |
| Chlorhexidine Gluconate Solution | 国药准字H20058443 | 化学药品 | 原料药 | 8/27/2020 | |
| Chlorhexidine Gluconate Solution | 国药准字H21021977 | 化学药品 | 溶液剂 | 5/9/2020 | |
| Chlorhexidine Acetate Suppositories | 国药准字H21020474 | 化学药品 | 栓剂 | 5/9/2020 | |
| Chlorhexidine Acetate Suppositories | 国药准字H20058601 | 化学药品 | 栓剂 | 8/30/2020 | |
| Chlorhexidine Acetate Suppositories | 国药准字H21021420 | 化学药品 | 栓剂 | 5/12/2020 | |
| Chlorhexidine Acetate Suppositories | 国药准字H13023027 | 化学药品 | 栓剂 | 6/14/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| COMFORDYL MOUTH WASH 0.2% W/V | N/A | N/A | N/A | 10/20/2005 | |
| SOLUPREP ANTISEPTIC LARGE WIPE | N/A | 3 m hong kong ltd | N/A | N/A | 12/23/2024 |
| QUALIDYL COLOR-FREE MOUTHRINSE 0.2% W/V | N/A | N/A | N/A | 2/15/2008 | |
| QUALIKIN 0.2%W/V MOUTHWASH | N/A | N/A | N/A | 12/11/1996 | |
| NEO-GUARD MOUTHWASH 0.2% | N/A | N/A | N/A | 11/28/2002 | |
| MARSEPT CUTANEOUS SOLUTION 2% W/V + 70% V/V | N/A | N/A | N/A | 4/19/2024 | |
| CHLORHEXIDINE SOLUTION 2% W/V IN ALCOHOL 70% V/V | N/A | N/A | N/A | 5/29/2020 | |
| CORSODYL DENTAL GEL 1% W/W | N/A | N/A | N/A | 6/6/1979 | |
| PORTLAND ANTISEPTIC GARGLE 0.2% | N/A | N/A | N/A | 8/15/2002 | |
| ATALA MOUTHWASH 0.2% | N/A | N/A | N/A | 7/26/2002 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| CHLORHEXIDINE 0.5% IN ALCOHOL 70% SOLUTION bottle | 11339 | Medicine | A | 8/13/1991 | |
| Bridgewest CHLORHEXIDINE 0.2% CATHETER PREP Irrigation Solution ampoule | 11324 | Medicine | A | 8/13/1991 | |
| CHLORHEXIDINE PRE-OP chlorhexidine gluconate 40mg/mL application tube | 11329 | Medicine | A | 8/13/1991 | |
| MICROSHIELD 4 CHLORHEXIDINE SURGICAL HANDWASH chlorhexidine gluconate 40mg/mL topical solution bag | 47524 | Medicine | A | 1/12/1994 | |
| CHLOROFLUOR GEL bottle | 21505 | Medicine | A | 10/8/1991 | |
| Chlorhexidine Irrigation Solution 0.1% | 279137 | Medicine | A | 8/15/2016 | |
| MICROSHIELD 2 SOLUTION | 447946 | Medicine | A | 5/7/2024 | |
| HYGI-PREP ANTIMICROBIAL WASH 4% chlorhexidine gluconate 4% w/v solution tube | 476325 | Medicine | A | 1/22/2025 | |
| PERIO PACK | 91660 | Medicine | A | 11/5/2002 | |
| Bridgewest CHLORHEXIDINE 0.05% CETRIMIDE 0.5% irrigation solution ampoule | 57011 | Medicine | A | 9/4/1996 |
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