Periogard Alcohol Free

Periogard Alcohol Free is an FDA-registered drug product whose active ingredient is CHLORHEXIDINE GLUCONATE. It is labelled by Colgate Oral Pharmaceuticals, Inc. taken by buccal and marketed as a human prescription drug product. Identifiers on file: NDC 0126-0282, application ANDA203212, label effective 20211014. It is one of 24 FDA drug label records sharing the active ingredient CHLORHEXIDINE GLUCONATE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing CHLORHEXIDINE GLUCONATE are most often described in connection with: usage periogard, chlorhexidine gluconate, oral rinse, usp indicated, dental visits, part professional, treatment gingivitis, characterized redness. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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 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.

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

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 .

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 of the salivary glands (sialadenitis) reported in patients using chlorhexidine gluconate oral rinse.

FDA lists 24 drug label records with CHLORHEXIDINE GLUCONATE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Periogard Alcohol Free used for?
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 …

Who makes Periogard Alcohol Free?
Colgate Oral Pharmaceuticals, Inc. is the labeler of record for Periogard Alcohol Free. 24 FDA label records share the active ingredient CHLORHEXIDINE GLUCONATE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Periogard Alcohol Free come in?
administered by buccal. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Periogard Alcohol Free prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing CHLORHEXIDINE GLUCONATE?
Yes. 24 FDA drug label records list CHLORHEXIDINE GLUCONATE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Periogard Alcohol Free been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.