The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 107, Llc for the product Major Oral Rinse (NDC 55154-3574). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding description, clinical pharmacology, pharmacokinetics, indication, contraindications, warnings, precautions, pregnancy: teratogenic effects, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
0.12% chlorhexidine gluconate (CHG) is an oral rinse
containing (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 product 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 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 becteria, 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 was equal to that as baseline.
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 in 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 occured primarily through the feces (~90%). Less than 1% of the chlorhexidine gluconate ingested by these subjects was excreted in the urine.
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.
Chlorhexidine gluconate oral rinse should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients.
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.
General:
1. For patients having coexisting gingivitis and periodontitis, the presence or absence of gingival inflammation following treatment with chlorhexidine gluconate oral rinse should not be used as a major indicator or underlying periodontitis
2. Chlorhexidine gluconate oral rinse can cause staining of oral surfaces, such as tooth surfaces, restorations, and the dorsum of the tongue. Not all patients will experience a visually significant increase in toothstaining. In clinical testing, 56% of chlorhexidine gluconate oral rinse users exhibited a measurable increase in facial anterior stain, compared to 35% of control users after six months; 15% of chlorhexidine gluconate oral rinse users developed what was judged to be heavy stain, compared to 1% of control users after six months. Stain will be more pronounced in patients who have heavier accumulations of unremoved plaque. Stain resulting from use of chlorhexidine gluconate oral rinse does not adversely affect health health of the gingivae or other oral tissues. Stain can be removed from most tooth surfaces by conventional professional prophylactic techniques. Additional time may be required to complete the prophylaxis, patients should be excluded from chlorhexidine gluconate oral rinse treatment if permanent discoloration is unacceptable. Stain in these areas may be difficuly to remove by dental prophylaxis and on rare occasions may necessitate replacement of these restorations.
3. Some patients may experience an alteration in taste perception while undergoing treatment with chlorhexidine gluconate oral rinse. Rare instances of permanent taste alteration following chlorhexidine gluconate oral rinse use have been reported via post-marketing product surveillance.
Reproduction studies have been performed in rats and rabbits at chlorhexidine gluconate doses up to 300mg/kg/day and 40mg/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 reproduciton studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when chlorhexidine gluconate oral rinse is administered to nursing women.
In parturition and lactation studies with rats, no evidence of impaired parturition or of toxic effects to suckling pups was observed when chlorhexidine gluconate was administered to dams at doses that were over 100 times greater than that which would result from a person's ingesting 30 ml of chlorhexidine gluconate oral rinse per day.
Clinical effectiveness and safey of chlorhexidine gluconate oral rinse have not been established in children under the age of 18.
In a drinking water study in rats, carcinogenic effects were not observed at doses up to 38mg/kg/day. Mutagenic effects were not observed in two mammalian in vivo mutagenisis studies with chlorhexidine gluconate. The highest doses of chlorhexidine used in a mouse dominant-lethal assay and a hamster cytogenisis test were 1000mg/kg/day and 250mg/kg/day, respectively. No evidence of impaired fertility was observed in rats at doses up to 100mg/kg/day.
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 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 occured 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 stomatits, 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.
Threre have been cases of parotid gland swelling and inflammation of the salivary glands (sialadenitis) reported in patients using chlorhexidine gluconate oral rinse.
Ingestion of 1 or 2 ounces of chlorhexidine gluconate oral rinse by a small child (~10kg 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.
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 linger than six months.
Recommended use is twice daily rinsing for 30 seconds, morning and evening after tooth brushing. Usual dosage os 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.
Chlorhexidine gluconate oral rinse is supplied as a blue liquid in 0.5-ounce (15 ml) white plastic unit dose cups:
Overbagged with 5 cups per bag (NDC 55154-3574-5)
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].
Your dentist has prescibed 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.
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.
If you have any questions or comments about chlorhexidine gluconate oral rinse, contact your dentist or pharmacist. Call your healthcare provider for medical advice about side effects. You may report side effects to Xttrium Laboratories at 1-800-587-3721 or FDA at 1-800-FDA-1088.
STORE at 20°C to 25°C (68°F to 77°F), 30°C (59°F to 86°F) [See USP controlled Room Temperature].
Rx Only.
KEEP OUT OF REACH OF CHILDREN.
Revised: September 2020
Distributed by:
MAJOR® PHARMACEUTICALS
17177 N Laurel Park Dr., Suite 233
Livonia, MI 48152
Chlorhexidine Gluconate Oral Rinse USP, 0.12%
0.12%/ 15 mL
5 Cups
Bag Label (Baad6ebb Ba44 4abe 8882 F2391d17d816 00)
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