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.
Background
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
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/05/03 | Phase 4 | Completed | Biochemical and Microbiology Laboratory, Faculty of Dentistry, Autonomous University of San Luis Pot | ||
2021/04/05 | Phase 2 | Completed | |||
2021/03/29 | Not Applicable | Completed | Istanbul University - Cerrahpasa (IUC) | ||
2021/02/16 | Phase 3 | Completed | |||
2021/02/10 | Phase 2 | Terminated | |||
2021/02/01 | Not Applicable | Completed | Plovdiv Medical University | ||
2021/01/26 | Not Applicable | Completed | |||
2021/01/25 | Not Applicable | Completed | |||
2021/01/22 | Phase 4 | Completed | |||
2021/01/22 | N/A | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Colgate Oral Pharmaceuticals, Inc. | 0126-0272 | BUCCAL | 1.2 mg in 1 mL | 11/18/2020 | |
| Xttrium Laboratories, Inc. | 0116-6720 | ORAL | 1.2 mg in 1 mL | 9/6/2022 | |
| ATLANTIC BIOLOGICALS CORP. | 17856-2002 | ORAL | 1.2 mg in 1 mL | 3/26/2020 | |
| Atlantic Biologicals Corps | 17856-2002 | ORAL | 1.2 mg in 1 mL | 3/26/2020 | |
| Bajaj Medical, LLC | 61037-469 | DENTAL | 1.2 mg in 1 mL | 1/2/2024 | |
| Dechra Veterinary Products | 17033-175 | TOPICAL | 20 mg in 1 mL | 6/6/2025 | |
| Xttrium Laboratories, Inc. | 0116-0101 | ORAL | 0.12 mg in 1 mL | 3/23/2020 | |
| H.J. Harkins Company, Inc. | 76519-1067 | ORAL | 1.2 mg in 1 mL | 8/27/2018 | |
| Xttrium Laboratories, Inc. | 0116-0137 | TOPICAL | 4 mg in 100 mL | 4/30/2025 | |
| Xttrium Laboratories, Inc. | 0116-0407 | TOPICAL | 4 g in 100 mL | 12/14/2023 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| SAVACOL ANTISEPTIC MOUTH & THROAT RINSE chlorhexidine gluconate 2 mg/mL mouthwash bottle - reformulation (alcohol free) | 380414 | Medicine | A | 12/8/2021 | |
| EVOCLENS-4 4% CHG ANTISEPTIC SURGICAL SCRUB SOLUTION chlorhexidine gluconate 4 % w/w bottle | 289014 | Medicine | A | 5/16/2017 | |
| SOLUPREP ANTISEPTIC SWAB SMALL (clear) medicated swab sachet | 226779 | Medicine | A | 8/11/2014 | |
| AVAGARD ANTISEPTIC CHG HAND RUB solution bottle | 77398 | Medicine | A | 2/12/2001 | |
| Chlorhexidine 0.015% and Cetrimide 0.15% Irrigation Solution | 278536 | Medicine | A | 8/1/2016 | |
| Perrigo Surgi-Prep C+ Red solution bottle | 319265 | Medicine | A | 6/25/2019 | |
| SAVLON ANTISEPTIC CREAM tube | 11247 | Medicine | A | 7/11/1991 | |
| SOOV cream tube | 10620 | Medicine | A | 8/2/1991 | |
| SAVACOL ANTISEPTIC MOUTH & THROAT RINSE MINT chlorhexidine gluconate 2 mg/mL mouthwash bottle | 11245 | Medicine | A | 7/11/1991 | |
| SOLUPREP ANTISEPTIC APPLICATOR solution | 226780 | Medicine | A | 8/11/2014 |