Periogard Alcohol Free 1.2 mg/mL

Chlorhexidine Gluconate · RINSE · Colgate Oral Pharmaceuticals, Inc.

No Recall History

Plain English

Periogard Alcohol Free is a rinse containing chlorhexidine gluconate at 1.2 mg/mL, taken buccal. Manufactured by Colgate Oral Pharmaceuticals, Inc..

Key Facts

Brand Name: Periogard Alcohol Free
Generic Name: Chlorhexidine Gluconate
NDC Code (Product): 0126-0282
Manufacturer: Colgate Oral Pharmaceuticals, Inc.
Strength: 1.2 mg/mL
Dosage Form: RINSE
Route: BUCCAL
Marketing Status
Application #: ANDA203212
Marketing Start: 10/04/2021

Recall History

No Recall History

Side Effects Reported to FDA

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

fatigue1,834 reports

joint swelling1,697 reports

rash1,693 reports

hypersensitivity1,629 reports

folliculitis1,619 reports

impaired healing1,594 reports

weight increased1,589 reports

pain1,586 reports

stomatitis1,542 reports

arthralgia1,526 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE PerioGard® (Chlorhexidine Gluconate Oral Rinse USP, 0.12%) 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. PerioGard® 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 PerioGard® (Chlorhexidine Gluconate Oral Rinse USP, 0.12%) therapy should be initiated directly following a dental prophylaxis. Patients using PerioGard® 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 1/2 fl. oz. ("15 mL" line in dosage cap) of undiluted PerioGard®. Patients should be instructed not to rinse with water or other mouthwashes, brush teeth, or eat immediately after using PerioGard®. PerioGard® is not intended for ingestion and should be expectorated after rinsing.

Warnings

WARNINGS The effect of PerioGard® on periodontitis has not been determined. An increase in supragingival calculus was noted in clinical testing with users of chlorhexidine gluconate oral rinse USP, 0.12% compared with control users. It is not known if chlorhexidine gluconate use results in an increase of 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 PerioGard® 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 rinse USP, 0.12% 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 1.0%. Among postmarketing reports, the most frequently reported oral mucosal symptoms associated with chlorhexidine gluconate oral rinse USP, 0.12% 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 chlorhexidine gluconate oral rinse. There have been cases of parotid gland swelling and inflammation…

Frequently Asked Questions

What is Periogard Alcohol Free used for?

Periogard Alcohol Free contains Chlorhexidine Gluconate. It is a rinse taken buccal. Consult your doctor for specific uses.

Is Periogard Alcohol Free a controlled substance?

Periogard Alcohol Free is not classified as a controlled substance by the DEA.

What is the generic name for Periogard Alcohol Free?

The generic name for Periogard Alcohol Free is Chlorhexidine Gluconate. There are 12 other brand versions of Chlorhexidine Gluconate.

What is the NDC code for Periogard Alcohol Free 1.2 mg/mL?

The NDC (National Drug Code) for Periogard Alcohol Free 1.2 mg/mL is 0126-0282, listed by Colgate Oral Pharmaceuticals, Inc..

Product NDC

0126-0282

Package NDC

0126-0282-16

Other Chlorhexidine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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