DENTI-CARE DENTI-RINSE CHLORHEXIDINE GLUCONATE ORAL RINSE

DENTI-CARE MEDICOM DENTI-RINSE 0.12 % CHLORHEXIDINE GLUCONATE ORAL RINSE MINT Item 10025-H Ingredients: 0.12 % chlorhexidine gluconate in a base containing water, 11.6 % alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin and FD and C Blue No.1. Rx Only KEEP OUT OF REACH OF CHILDREN 1 Pint (473 ml) NDC 64778-0244-1 M0701707V.2 DIRECTIONS FOR USE: Fill cap to the “fill line” (15 mL). Swish in mouth undiluted for 30 seconds, then spit out. Use after breakfast and before bedtime. Or, use as prescribed. NOTE: To minimize medicinal taste, do not rinse with water immediately after use. To open: Squeeze smooth areas near bottom of cap and turn. To close: Turn Cap until it locks. WHAT TO EXPECT WHEN USING CHLORHEXIDINE GLUCONATE ORAL RINSE Your dentist has prescribed chlorhexidine gluconate oral rinse 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. 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. • Local hypersensitivity and sometimes generalized allergic reactions have also been reported. Chlorhexidine gluconate oral rinse should not be used by persons who have a sensitivity to it or its components. • 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. Store at USP Controlled Room Temperature (20°C - 25°C (68°F - 77°F)). Manufactured for and distributed by: AMD Medicom Inc. 2555 Chemin de l'Aviation Pointe-Claire, Montreal, Quebec, Canada H9P 2Z2 DESCRIPTION: Chlorhexidine gluconate is an oral rinse containing 0.12% chlorhexidine gluconate (1,11-hexamethylene bis[5-(p-chlorophenyl) biguanide] di-D-gluconate) in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD and C Blue No.1. Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid.

INDICATION: Chlorhexidine gluconate oral rinse 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 has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis; see PRECAUTIONS.

: DOSAGE AND ADMINISTRATION: Chlorhexidine gluconate oral rinse therapy should be initiated directly following a dental prophylaxis. Patients using chlorhexidine gluconate oral rinse should be reevaluated and given a thorough prophylaxis at intervals of no longer than six months. Recommended use is twice daily rinsing for 30 seconds, morning and evening after tooth brushing. Usual dosage is 15 mL (marked in cap) of undiluted chlorhexidine gluconate oral rinse. Patients should be instructed to not rinse with water, or other mouthwashes, brush teeth, or eat immediately after using chlorhexidine gluconate oral rinse. Chlorhexidine gluconate oral rinse is not intended for ingestion and should be expectorated after rinsing.

: Chlorhexidine gluconate oral rinse should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients.

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 symptomshave been spontaneously reported as side effects associated with use of chlorhexidinegluconate rinse. The following oral mucosal side effects were reported duringplacebo-controlled adult clinical trials: aphthous ulcer, grossly obvious gingivitis,trauma, ulceration, erythema, desquamation, coated tongue, keratinization, geographictongue, mucocele, and short frenum. Each occurred at a frequency of less than 1.0%. Among post marketing 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.