Chlorhexidine Gluconate
Patterson Dental Supply Inc.
Human Prescription Drug
NDC 50227-0101Chlorhexidine Gluconate is a human prescription drug labeled by 'Patterson Dental Supply Inc.'. National Drug Code (NDC) number for Chlorhexidine Gluconate is 50227-0101. This drug is available in dosage form of Rinse. The names of the active, medicinal ingredients in Chlorhexidine Gluconate drug includes Chlorhexidine Gluconate - 1.2 mg/mL . The currest status of Chlorhexidine Gluconate drug is Active.
Drug Information:
| Drug NDC: | 50227-0101 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Chlorhexidine Gluconate |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Chlorhexidine Gluconate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Patterson Dental Supply Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Rinse |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | CHLORHEXIDINE GLUCONATE - 1.2 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 30 Jun, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 31 Jul, 2023 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | ANDA077789 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 25 Dec, 2025 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Patterson Dental Supply Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 834127
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | MOR84MUD8E
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Decreased Cell Wall Integrity [PE]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 50227-0101-1 | 473 mL in 1 BOTTLE, PLASTIC (50227-0101-1) | 30 Jun, 2017 | 31 Jul, 2023 | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Chlorhexidine gluconate chlorhexidine gluconate chlorhexidine gluconate chlorhexidine
Warnings and Cautions:
Warnings and 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. precautions 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 of underlying periodontitis. 2. chlorhexidine gluconate oral rinse can cause staining of oral surfaces, such as tooth surface
Read more...s, restorations, and the dorsum of the tongue. not all patients will experience a visually significant increase in tooth staining. 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 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. discretion should be used when prescribing to patients with anterior facial restorations with rough surfaces or margins. if natural stain cannot be removed from these surfaces by a dental prophylaxis, patients should be excluded from chlorhexidine gluconate oral rinse treatment if permanent discoloration is unacceptable. stain in these areas may be difficult 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.
Dosage and Administration:
Dosage & administration 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 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.
Contraindications:
Contraindications 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:
Adverse reactions 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
Read more... 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.
Use in Pregnancy:
Pregnancy pregnancy : teratogenic effects pregnancy category b. 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:
Pediatric pediatric use : clinical effectiveness and safety of chlorhexidine gluconate oral rinse have not been established in children under the age of 18.
Overdosage:
Overdosage 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.
Clinical Pharmacology:
Clinical pharmacology clinical pharmacology : chlorhexidine gluconate oral rinse provides antimicrobial activity during oral rinsing. the clinical significance of chlorhexidine gluconate oral rinseâs 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:
Pharmacokinetics 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 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 occurred primarily through the feces (~90%). less than 1% of the chlorhexidine gluconate ingested by these subjects was excreted in the urine.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis & mutagenesis & impairment of fertility 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 1,000 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:
How supplied how supplied : chlorhexidine gluconate oral rinse is supplied as blue liquid in 4-ounce (118 ml) and 1-pint (473 ml) amber plastic bottles with child-resistant dispensing closures, ndc 50227-0101-1.
Information for Patients:
What to expect when using chlorhexidine gluconate 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. 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 to 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 t
Read more...o 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 that 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, pharmacist or call toll free at 1-800-361-2862. call your health care provider for medical advice about side effects. you may report side effects to fda at 1-800-fda-1088.
Package Label Principal Display Panel:
Principal panel ndc 50227-0101-1 panel 1