Drugplain

Peridex 1.2 mg/mL

chlorhexidine gluconate · RINSE · Solventum US LLC

No Recall History
Plain English

Peridex is a rinse containing chlorhexidine gluconate at 1.2 mg/mL, taken oral. Manufactured by Solventum US LLC.

Key Facts

Brand Name
Peridex
Generic Name
chlorhexidine gluconate
NDC Code (Product)
48878-0620
Manufacturer
Solventum US LLC
Strength
1.2 mg/mL
Dosage Form
RINSE
Route
ORAL
Marketing Status
Application #
NDA019028
Marketing Start
08/13/1986

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

fatigue1,905 reports
joint swelling1,672 reports
rash1,671 reports
pain1,664 reports
hypersensitivity1,599 reports
impaired healing1,594 reports
folliculitis1,586 reports
weight increased1,566 reports
arthralgia1,559 reports
stomatitis1,537 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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 & 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.

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 .

Contraindications

CONTRAINDICATIONS: Peridex should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients.

Adverse Reactions

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.

Frequently Asked Questions

What is Peridex used for?

Peridex contains chlorhexidine gluconate. It is a rinse taken oral. Consult your doctor for specific uses.

Is Peridex a controlled substance?

Peridex is not classified as a controlled substance by the DEA.

What is the generic name for Peridex?

The generic name for Peridex is chlorhexidine gluconate. There are 12 other brand versions of chlorhexidine gluconate.

What is the NDC code for Peridex 1.2 mg/mL?

The NDC (National Drug Code) for Peridex 1.2 mg/mL is 48878-0620, listed by Solventum US LLC.