Peridex
Chlorhexidine gluconate · Rinse · Oral
Uses
INDICATION: Peridex is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Peridex has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS .
Dosage and administration
DOSAGE AND ADMINISTRATION: Peridex therapy should be initiated directly following a dental prophylaxis. Patients using Peridex should be reevaluated and given a thorough prophylaxis at intervals no longer than six months. Recommended use is twice daily oral rinsing for 30 seconds, morning and evening after toothbrushing. Usual dosage is 15ml (marked in cap) of undiluted Peridex. Patients should be instructed to not rinse with water or other mouthwashes, brush teeth or eat immediately after using Peridex. Peridex is not intended for ingestion and should be expectorated after rinsing.
Contraindications
CONTRAINDICATIONS: Peridex should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients.
Warnings
WARNINGS: The effect of Peridex on periodontitis has not been determined. An increase in supragingival calculus was noted in clinical testing in Peridex users compared with control users. It is not known if Peridex use results in an increase in subgingival calculus. Calculus deposits should be removed by a dental prophylaxis at intervals not greater than six months. Anaphylaxis, as well as serious allergic reactions, have been reported during postmarketing use with dental products containing chlorhexidine. SEE CONTRAINDICATIONS .
Precautions
PRECAUTIONS: General: For patients having coexisting gingivitis and periodontitis, the presence or absence of gingival inflammation following treatment with Peridex should not be used as a major indicator of underlying periodontitis. Peridex can cause staining of oral surfaces, such as tooth surfaces, restorations, and the dorsum of the tongue. Not all patients will experience a visually significant increase in toothstaining. In clinical testing, 56% of Peridex users exhibited a measurable increase in facial anterior stain, compared to 35% of control users after six months; 15% of Peridex users developed what was judged to be heavy stain, compared to 1% of control users after six months. Stain will be more pronounced in patients who have heavier accumulations of unremoved plaque. Stain resulting from use of Peridex does not adversely affect health of the gingivae or other oral tissues. Stain can be removed from most tooth surfaces by conventional professional prophylactic techniques. Additional time may be required to complete the prophylaxis. Discretion should be used when prescribing to patients with anterior facial restorations with rough surfaces or margins. If natural stain cannot be removed from these surfaces by a dental prophylaxis, patients should be excluded from Peridex treatment if permanent discoloration is unacceptable. Stain in these areas may be difficult to remove by dental prophylaxis and on rare occasions may necessitate replacement of these restorations. Some patients may experience an alteration in taste perception while undergoing treatment with Peridex. Rare instances of permanent taste alteration following Peridex use have been reported via post-marketing product surveillance. Pregnancy: Teratogenic Effects. Reproduction studies have been performed in rats and rabbits at chlorhexidine gluconate doses up to 300mg/kg/day and 40mg/kg/day, respectively, and have not revealed evidence of harm to fetus. However, adequate and well-controlled studies in pregnant women have not been done. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Peridex is administered to nursing women. In parturition and lactation studies with rats, no evidence of impaired parturition or of toxic effects to suckling pups was observed when chlorhexidine gluconate was administered to dams at doses that were over 100 times greater than that which would result from a person's ingesting 30ml (2 capfuls) of Peridex per day. Pediatric Use: Clinical effectiveness and safety of Peridex™ (Chlorhexidine Gluconate 0.12%) Oral Rinse have not been established in children under the age of 18. Carcinogenesis, Mutagenesis, and Impairment of Fertility: In a drinking water study in rats, carcinogenic effects were not observed at doses up to 38mg/kg/day. Mutagenic effects were not observed in two mammalian in vivo mutagenesis studies with chlorhexidine gluconate. The highest doses of chlorhexidine used in a mouse dominant-lethal assay and a hamster cytogenetics test were 1000mg/kg/day and 250mg/kg/day, respectively. No evidence of impaired fertility was observed in rats at doses up to 100mg/kg/day.
Side effects
ADVERSE REACTIONS: The most common side effects associated with chlorhexidine gluconate oral rinses are: 1) an increase in staining of teeth and other oral surfaces; 2) an increase in calculus formation; and 3) an alteration in taste perception, see WARNINGS and PRECAUTIONS . Oral irritation and local allergy-type symptoms have been spontaneously reported as side effects associated with use of chlorhexidine gluconate rinse. The following oral mucosal side effects were reported during placebo-controlled adult clinical trials: aphthous ulcer, grossly obvious gingivitis, trauma, ulceration, erythema, desquamation, coated tongue, keratinization, geographic tongue, mucocele, and short frenum. Each occurred at a frequency of less than 1%. Among post marketing reports, the most frequently reported oral mucosal symptoms associated with Peridex are stomatitis, gingivitis, glossitis, ulcer, dry mouth, hypesthesia, glossal edema, and paresthesia. Minor irritation and superficial desquamation of the oral mucosa have been noted in patients using Peridex. There have been cases of parotid gland swelling and inflammation of the salivary glands (sialadenitis) reported in patients using Peridex.
Pregnancy
Pregnancy: Teratogenic Effects. Reproduction studies have been performed in rats and rabbits at chlorhexidine gluconate doses up to 300mg/kg/day and 40mg/kg/day, respectively, and have not revealed evidence of harm to fetus. However, adequate and well-controlled studies in pregnant women have not been done. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Pediatric use
Pediatric Use: Clinical effectiveness and safety of Peridex™ (Chlorhexidine Gluconate 0.12%) Oral Rinse have not been established in children under the age of 18.
Overdosage
OVERDOSAGE: Ingestion of 1 or 2 ounces of Peridex by a small child (~1O kg body weight) might result in gastric distress, including nausea, or signs of alcohol intoxication. Medical attention should be sought if more than 4 ounces of Peridex is ingested by a small child or if signs of alcohol intoxication develop.
Description
DESCRIPTION: Peridex™ (Chlorhexidine Gluconate 0.12%) Oral Rinse is an oral rinse containing 0.12% chlorhexidine gluconate (1, 1 1 -hexamethylene bis [5-(p-chlorophenyl) biguanide] di-D-gluconate) in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD&C Blue No. 1. Peridex is a near-neutral solution (pH range 5-7). Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. Its chemical structure is: Chemical Structure
How supplied
HOW SUPPLIED: Peridex is supplied as a blue liquid in 4-ounce (118ml), 1-pint (473ml) and 64-ounce (1893ml) white or amber plastic bottles with child-resistant dispensing closures. STORE at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP controlled Room Temperature]. Rx only Keep out of reach of children Revised: July 2022 Made in U.S.A. for: 3M ESPE Dental Products 2510 Conway Avenue St. Paul, MN 55144-1000 USA ©3M 2022
Storage
STORE at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP controlled Room Temperature]. Rx only Keep out of reach of children Revised: July 2022 Made in U.S.A. for: 3M ESPE Dental Products 2510 Conway Avenue St. Paul, MN 55144-1000 USA ©3M 2022
Label text from the FDA structured product label by Solventum US LLC (revised Aug 1, 2024). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Chlorhexidine Gluconate in 1 product
Peridex NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 48878-0620 | Chlorhexidine Gluconate 1.2 mg/mL Rinse | Solventum US LLC | NDA |
Frequently asked questions
What is Peridex used for?
INDICATION: Peridex is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Peridex has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see…
What are the side effects of Peridex?
ADVERSE REACTIONS: The most common side effects associated with chlorhexidine gluconate oral rinses are: 1) an increase in staining of teeth and other oral surfaces; 2) an increase in calculus formation; and 3) an alteration in taste perception, see WARNINGS and PRECAUTIONS . Oral irritation and local allergy-type symptoms have been spontaneously reported as side effects associated with use of… See the full label for the complete list.
Who makes Peridex?
Peridex is listed by 1 labeler in the FDA NDC directory, including Solventum US LLC.