Complete SPL Sections#
DESCRIPTION
DESCRIPTION SECTION
Chlorhexidine Gluconate Oral Rinse, 0.12% 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 11.6% alcohol, FD&C Blue No. 1, glycerin, peppermint flavor, polysorbate 80, purified water, and saccharin sodium. Chlorhexidine Gluconate Oral Rinse, 0.12% is a near-neutral solution (pH range 5-7). Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. Its chemical structure is: C 22 H 30 CI 2 N 10 ∙2C 6 H 12 O 7 M.W. 897.72
CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY SECTION
Chlorhexidine gluconate oral rinse, 0.12% provides antimicrobial activity during oral rinsing. The clinical significance of 0.12% chlorhexidine gluconate oral rinse's antimicrobial activities is not clear. Microbiological sampling of plaque has shown a general reduction of counts of certain assayed bacteria, both aerobic and anaerobic, ranging from 54-97% through six months use. Use of chlorhexidine gluconate oral rinse in a six month clinical study did not result in any significant changes in bacteria resistance, overgrowth of potentially opportunistic organisms or other adverse changes in the oral microbial ecosystem. Three months after chlorhexidine gluconate oral rinse use was discontinued, the number of bacteria in plaque had returned to baseline levels and resistance of plaque bacteria to chlorhexidine gluconate was equal to that at baseline.
INDICATIONS AND USAGE
INDICATIONS & USAGE SECTION
Chlorhexidine gluconate oral rinse, 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. Chlorhexidine gluconate oral rinse, 0.12% has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS .
CONTRAINDICATIONS
CONTRAINDICATIONS SECTION
Chlorhexidine gluconate oral rinse, 0.12% should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients.
WARNINGS
WARNINGS SECTION
The effect of chlorhexidine gluconate oral rinse, 0.12% on periodontitis has not been determined. An increase in supragingival calculus was noted in clinical testing in chlorhexidine gluconate oral rinse users compared with control users. It is not known if chlorhexidine gluconate 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 SECTION
ADVERSE REACTIONS
ADVERSE REACTIONS SECTION
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 the use of chlorhexidine gluconate oral 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 postmarketing reports, the most frequently reported oral mucosal symptoms associated with chlorhexidine gluconate oral rinse 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. To report SUSPECTED ADVERSE REACTIONS, contact Pharmaceutical Associates, Inc. at 1-800-845-8210 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
OVERDOSAGE
OVERDOSAGE SECTION
Ingestion of 1 or 2 ounces of chlorhexidine gluconate oral rinse, 0.12% by a small child (~10 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 chlorhexidine gluconate oral rinse, 0.12% is ingested by a small child or if signs of alcohol intoxication develop.
DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION SECTION
Chlorhexidine gluconate oral rinse, 0.12% therapy should be initiated directly following a dental prophylaxis. Patients using chlorhexidine gluconate oral rinse, 0.12% 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 15 mL of undiluted chlorhexidine gluconate oral rinse, 0.12%. Patients should be instructed to not rinse with water or other mouthwashes, brush teeth or eat immediately after using chlorhexidine gluconate oral rinse, 0.12%. Chlorhexidine gluconate oral rinse, 0.12% is not intended for ingestion and should be expectorated after rinsing.
HOW SUPPLIED
HOW SUPPLIED SECTION
Chlorhexidine Gluconate Oral Rinse, 0.12% is a blue, peppermint flavored liquid and is supplied as: NDC 0121-0893-04: 4 fl oz (118 mL) NDC 68071-2377-6: 16 fl oz (473 mL)
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
MANUFACTURED BY Pharmaceutical Associates, Inc. Greenville, SC 29605 www.paipharma.com R03/20
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
What To Expect When Using Chlorhexidine Gluconate Oral Rinse, 0.12% Your dentist has prescribed chlorhexidine gluconate oral rinse, 0.12% to treat your gingivitis, to help reduce the redness and swelling of your gums, and also to help you control any gum bleeding. Use chlorhexidine gluconate oral rinse regularly, as directed by your dentist, in addition to daily brushing. Spit out after use. Chlorhexidine gluconate oral rinse should not be swallowed. If you develop allergic symptoms such as skin rash, itch, generalized swelling, breathing difficulties, light headedness, rapid heart rate, upset stomach or diarrhea, seek medical attention immediately. Chlorhexidine gluconate oral rinse should not be used by persons who have a sensitivity to it or its components. Chlorhexidine gluconate oral rinse may cause some tooth discoloration or increase in tartar (calculus) formation, particularly in areas where stain and tartar usually form. It is important to see your dentist for removal of any stain or tartar at least every six months or more frequently if your dentist advises. Both stain and tartar can be removed by your dentist or hygienist. Chlorhexidine gluconate oral rinse may cause permanent discoloration of some front-tooth fillings. To minimize discoloration, you should brush and floss daily, emphasizing areas which begin to discolor. Chlorhexidine gluconate oral rinse may taste bitter to some patients and can affect how foods and beverages taste. This will become less noticeable in most cases with continued use of chlorhexidine gluconate oral rinse. To avoid taste interference, rinse with chlorhexidine gluconate oral rinse after meals. Do not rinse with water or other mouthwashes immediately after rinsing with chlorhexidine gluconate oral rinse. If you have any questions or comments about chlorhexidine gluconate oral rinse, contact your dentist or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to Pharmaceutical Associates, Inc. at 1-800-845-8210 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. MANUFACTURED BY Pharmaceutical Associates, Inc. Greenville, SC 29605 www.paipharma.com R03/20
PRINCIPAL DISPLAY PANEL - 16 oz (473 mL) Bottle Label
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
