Chlorhexidine Gluconate, 0.12% Oral Rinse Solution is a human prescription drug labeled by 'Bajaj Medical, Llc'. National Drug Code (NDC) number for Chlorhexidine Gluconate, 0.12% Oral Rinse Solution is 61037-469. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Chlorhexidine Gluconate, 0.12% Oral Rinse Solution drug includes Chlorhexidine Gluconate - 1.2 mg/mL . The currest status of Chlorhexidine Gluconate, 0.12% Oral Rinse Solution drug is Active.

Chlorhexidine gluconate, 0.12% oral rinse solution chlorhexidine gluconate, 0.12% oral rinse solution fd&c blue no. 1 glycerin saccharin sodium chlorhexidine gluconate chlorhexidine peg-40 sorbitan diisostearate alcohol water

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.

Warnings the effect of chlorhexidine gluconate oral rinse 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 oral rinse 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.

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 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.

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

Adverse reactions 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 supe Read more...

Pregnancy: teratogenic effects reproduction studies have been performed in rats and rabbits at chlorhexidine gluconate doses up to 300 mg/kg/day and 40 mg/kg/day, respectively, and have not revealed evidence of harm to fetus. however, adequate and well-controlled studies in pregnant women have not been done. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Pediatric use clinical effectiveness and safety of chlorhexidine gluconate oral rinse have not been established in children under the age of 18.

Overdosage ingestion of 1 or 2 ounces of chlorhexidine gluconate oral rinse 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 is ingested by a small child or if signs of alcohol intoxication develop.

Description 0.12% chlorhexidine gluconate (chg) is an oral rinse containing (1, 1'-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 product is a near-neutral solution (ph range 5-7). chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. its chemical structure is: struc

Clinical pharmacology chlorhexidine gluconate oral rinse provides antimicrobial activity during oral rinsing. the clinical significance of 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 bacterial 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. pharmacokinetics pharmacokinetic studies with chlorhexidine gluconate oral rinse indicate approximately 30% of the acti Read more...

Pharmacokinetics pharmacokinetic studies with chlorhexidine gluconate oral rinse indicate approximately 30% of the active ingredient, chlorhexidine gluconate, is retained in the oral cavity following rinsing. this retained drug is slowly released into the oral fluids. studies conducted on human subjects and animals demonstrate chlorhexidine gluconate is poorly absorbed from the gastrointestinal tract. the mean plasma level of chlorhexidine gluconate reached a peak of 0.206 mcg/g in humans 30 minutes after they ingested a 300-mg dose of the drug. detectable levels of chlorhexidine gluconate were not present in the plasma of these subjects 12 hours after the compound was administered. excretion of chlorhexidine gluconate occurred primarily through the feces (~90%). less than 1% of the chlorhexidine gluconate ingested by these subjects was excreted in the urine.

Carcinogenesis, mutagenesis, and impairment of fertility in a drinking water study in rats, carcinogenic effects were not observed at doses up to 38 mg/kg/day. mutagenic effects were not observed in two mammalian in vivo mutagenesis studies with chlorhexidine gluconate. the highest doses of chlorhexidine used in a mouse dominant-lethal assay and a hamster cytogenetics test were 1000 mg/kg/day and 250 mg/kg/day, respectively. no evidence of impaired fertility was observed in rats at doses up to 100 mg/kg/day.

How supplied chlorhexidine gluconate oral rinse is supplied as a blue liquid in 1-pint (473 ml) amber plastic bottle with child-resistant dispensing closure and 1-pint (473 ml) amber plastic bottle with child-resistant closure, 4-ounce (118 ml) amber plastic bottle with child-resistant closure, 64-ounce (1893 ml) white plastic bottle with foam-lined closure and 15 ml unit-dose cup. store at 20°c to 25°c (68°f to 77°f), excursions permitted to 15°c to 30°c (59°f to 86°f) [see usp controlled room temperature]. rx only. revised: november 2021 manufactured by: bajaj medical 415 w pershing rd. chicago, il 60609 usa

Ndc 61037-469-02 chlorhexidine gluconate 0.12% oral rinse, usp directions for use: swish 1 tablespoon (15ml) 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. ingredients: 0.12% chlorhexidine gluconate in a base containing water, 11.6% alcohol, glycerin, peg-40 sorbitan diisostearate, flavor, sodium saccharin and fd&c blue no. 1. to open, press down while turning cap. to reseal, turn cap past “clicks” until tightly locked rx only keep out of reach of children 4 oz. (118 ml) ndc 61037-469-03 chlorhexidine gluconate 0.12% oral rinse, usp 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. ingredients: 0.12% chlorhexidine gluconate in a base containing water, 11.6% alcohol, glycerin, peg-40 sorbitan diisostearate, flavor, sodium saccharin and fd&c blue no. 1. to open: squeeze smooth areas near bottom of cap and turn. to close: turn cap until it locks. rx only keep out of reach of children 1 pint (473 ml) dispense in bottle provided or amber glass ndc 61037-469-05 chlorhexidine gluconate 0.12% oral rinse, usp directions for use: dispense 15 ml of the oral rinse into a suitable patient cup. swish in mouth undiluted for 30 seconds, then spit out. note: to minimize medicinal taste, do not rinse with water immediately after use. ingredients: 0.12% chlorhexidine gluconate in a base containing water, 11.6% alcohol, glycerin, peg-40 sorbitan diisostearate, flavor, sodium saccharin and fd&c blue no. 1. rx only keep out of reach of children 64 fl oz (1893 ml) ndc 61037-469-07 chlorhexidine gluconate 0.12% oral rinse, usp directions for use: 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. ingredients: 0.12% chlorhexidine gluconate in a base containing water, 11.6% alcohol, glycerin, peg-40 sorbitan diisostearate, flavor, sodium saccharin and fd&c blue no. 1. rx only keep out of reach of children 100 unit dose cups (each cup delivers 15 ml) 4oz1 4oz2 4oz3 4oz4 4oz5 16oz1 16oz2 16oz3 64oz1 64oz2 64oz3 15ml1 15ml2 15ml3