Chlorhexidine Gluconate Oral Rinse

CHLORHEXIDINE GLUCONTATE 0.12% ORAL RINSE 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&C Blue No. 1. Chlorhexidine Gluconate is a near-neutral solution (pH range 5-7). Chlorhexidine Gluconate is a salt of chlorhexidine and gluconic acid. Its chemical structure is: Chlorhexidine Gluconate Structure

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. USES helps reduce bacteria that can potentially cause skin infection for preparation of skin prior to surgery

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 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. 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. DIRECTIONS use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. do not microwave product and packaging are not sterile. Follow your hospital policy for skin preparation with non-sterile products. To open package holding top of package in one hand, lift flap on backside of package with other hand grasp flap at top and pull down to tear flap away and expose foam hold outside of package to present foam and cloths to prep table, avoiding contact between cloths and outside of package to reduce risk of cloth contamination Or using sterile scissors, cut off end seal of package transfer contents onto prep table, avoiding contact between cloths and outside of package to reduce risk of cloth contamination use first cloth to prepare the skin area indicated for a moist or dry site, making certain to keep the second cloth where it will not be contaminated. Use second cloth to prepare larger areas. dry surgical sites (such as abdomen or arm): use one cloth to cleanse each 161 cm2 area (approximately 5 x 5 inches) of skin to be prepared. Vigorously scrub skin back and forth for 3 minutes, completely wetting treatment area, then discard. Allow area to air dry for one (1) minute. Do not rinse. moist surgical sites (such as inguinal fold): use one cloth to cleanse each 65 cm2 area (approximately 2 x 5 inches) of skin to be prepared. Vigorously scrub skin back and forth for 3 minutes, completely wetting treatment area, then discard. Allow area to air dry for one (1) minute. Do not rinse. discard each cloth after a single use after package has been opened discard any unused cloths Other information store product flat store between 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F)

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 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%. 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.

KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away.

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