Major Oral Rinse
0.12% Chlorhexidine Gluconate
Major Pharmaceuticals
Human Prescription Drug
NDC 0904-7035Major Oral Rinse also known as 0.12% Chlorhexidine Gluconate is a human prescription drug labeled by 'Major Pharmaceuticals'. National Drug Code (NDC) number for Major Oral Rinse is 0904-7035. This drug is available in dosage form of Rinse. The names of the active, medicinal ingredients in Major Oral Rinse drug includes Chlorhexidine Gluconate - 1.2 mg/mL . The currest status of Major Oral Rinse drug is Active.
Drug Information:
| Drug NDC: | 0904-7035 |
| 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: | Major Oral Rinse |
| 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: | 0.12% Chlorhexidine Gluconate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Major Pharmaceuticals |
| 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: | 20 Nov, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 Dec, 2025 |
| 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: | 31 Dec, 2023 |
| 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: | Major Pharmaceuticals
|
| 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. |
| UPC: | 0309047035885
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 0904-7035-80 | 1500 mL in 1 PACKAGE (0904-7035-80) | 20 Nov, 2020 | N/A | No |
| 0904-7035-87 | 600 mL in 1 PACKAGE (0904-7035-87) | 20 Nov, 2020 | N/A | No |
| 0904-7035-88 | 15 mL in 1 CUP, UNIT-DOSE (0904-7035-88) | 20 Nov, 2020 | N/A | 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:
Major oral rinse 0.12% chlorhexidine gluconate saccharin sodium glycerin chlorhexidine gluconate chlorhexidine water alcohol fd&c blue no. 1
Indications and Usage:
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:
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:
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 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.
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 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 s
Read more...uperficial 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.
Use in Pregnancy:
Pregnancy: teratogenic effects 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.
Pediatric Use:
Pediatric use clinical effectiveness and safey of chlorhexidine gluconate oral rinse have not been established in children under the age of 18.
Overdosage:
Overdosage 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.
Description:
Description 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: mjr chem structure
Clinical Pharmacology:
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 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.
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 occured 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:
Carcinogenisis, mutagenisis, and impairment of fertility 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.
How Supplied:
How supplied chlorhexidine gluconate oral rinse is supplied as a blue liquid in 0.5-ounce (15 ml) (ndc 0904-7035-88) white plastic unit dose cups, 0.5-ounce (15 ml) (ndc 0904-7035-87) white plastic unit dose cups (40 pack) and 0.5-ounce (15 ml) (ndc 0904-7035-80) white plastic unit dose cups (100 pack). store at 20ºc to 25ºc (68ºf to 77ºf), excursions permitted to 15ºc to 30ºc (59ºf to 86ºf) [see usp controlled room temperature].
Package Label Principal Display Panel:
Ndc 0904-7035-88 chlorhexidine gluconate oral rinse usp, 0.12% 0.12% / 15 ml delivers 15 ml see insert for institutional use only ⢠rx only major® pharmaceuticals livonia, mi 48152 1999mjrlidlbl 1999mjrudinst mjr lid mjr inst1 mjr inst2 mjr inst3 mjr inst4