Periogard Alcohol Free
Generic: CHLORHEXIDINE GLUCONATE
Basic Information
Manufacturer
ATLANTIC BIOLOGICALS CORP.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
BUCCAL
FDA Set ID
f927717e-e743-43c4-a2b3-d5b83f2403b0
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 .
PerioGard® has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG).
For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS .
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 .
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
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.
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.