NDC 0116-0244 Denti-care Denti-rinse Chlorhexidine Gluconate Oral Rinse

Chlorhexidine Gluconante

NDC Product Code 0116-0244

NDC CODE: 0116-0244

Proprietary Name: Denti-care Denti-rinse Chlorhexidine Gluconate Oral Rinse What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Chlorhexidine Gluconante What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used along with regular tooth brushing/flossing to treat gingivitis, a gum disease that causes red, swollen, and easily bleeding gums. Chlorhexidine belongs to a class of drugs known as antimicrobials. It works by decreasing the amount of bacteria in the mouth, helping to reduce swelling and redness of the gums and bleeding when you brush.

NDC Code Structure

  • 0116 - Xttrium Laboratories, Inc.

NDC 0116-0244-01

Package Description: 473 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Denti-care Denti-rinse Chlorhexidine Gluconate Oral Rinse with NDC 0116-0244 is a a human prescription drug product labeled by Xttrium Laboratories, Inc.. The generic name of Denti-care Denti-rinse Chlorhexidine Gluconate Oral Rinse is chlorhexidine gluconante. The product's dosage form is liquid and is administered via dental form.

Labeler Name: Xttrium Laboratories, Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Denti-care Denti-rinse Chlorhexidine Gluconate Oral Rinse Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • CHLORHEXIDINE GLUCONATE 1.2 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • PEG-40 SORBITAN DIISOSTEARATE (UNII: JL4CCU7I1G)
  • ALCOHOL (UNII: 3K9958V90M)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Dental - Administration to a tooth or teeth.
  • Dental - Administration to a tooth or teeth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Decreased Cell Wall Integrity - [PE] (Physiologic Effect)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Xttrium Laboratories, Inc.
Labeler Code: 0116
FDA Application Number: ANDA077789 What is the FDA Application Number?
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.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 06-02-2006 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Denti-care Denti-rinse Chlorhexidine Gluconate Oral Rinse Product Label Images

Denti-care Denti-rinse Chlorhexidine Gluconate Oral Rinse Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

DENTI-CAREMEDICOM

DENTI-RINSE

0.12 % CHLORHEXIDINE GLUCONATE ORAL RINSE

MINT

Item 10025-H

Ingredients: 0.12 % chlorhexidine gluconate in a base containing water, 11.6 % alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin and FD and C Blue No.1.
Rx Only KEEP OUT OF REACH OF CHILDREN

1 Pint (473 ml)

NDC 64778-0244-1

M0701707V.2
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.
To open: Squeeze smooth areas near bottom of cap and turn.To close: Turn Cap until it locks.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. 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. • 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 which begin to discolor. • Local hypersensitivity and sometimes generalized allergic reactions have also been reported. Chlorhexidine gluconate oral rinse should not be used by persons who have a sensitivity to it or its components. • 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 or pharmacist.Store at USP Controlled Room Temperature (20°C - 25°C (68°F - 77°F)).Manufactured for and distributed by:AMD Medicom Inc. 2555 Chemin de l'Aviation Pointe-Claire, Montreal, Quebec, Canada H9P 2Z2 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 and C Blue No.1. Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid.

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 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: 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 μg/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 that 1% of the chlorhexidine gluconate
ingested by these subjects was excreted in the urine.

Indications & 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.

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.

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. Hypersensitivity
and generalized allergic reactions have occurred; SEE CONTRAINDICATIONS.

Precautions

PRECAUTIONS: General:1. For patients having coexisting gingivitis and periodontitis, the presence of 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
surfaces, 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 of 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.


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.


Nursing Mothers: 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 (2 capfuls) of chlorhexidine gluconate oral rinse
per day.


Pediatric Use: Clinical effectiveness and safety of chlorhexidine gluconate oral rinse
have not been established in children under age of 18.



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.

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 symptomshave been spontaneously reported as side effects associated with use of chlorhexidinegluconate rinse. The following oral mucosal side effects were reported duringplacebo-controlled adult clinical trials: aphthous ulcer, grossly obvious gingivitis,trauma, ulceration, erythema, desquamation, coated tongue, keratinization, geographictongue, mucocele, and short frenum. Each occurred at a frequency of less than 1.0%.


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.

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.

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 of 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.

How Supplied

HOW SUPPLIED: Chlorhexidine gluconate oral rinse is supplied as a blue liquid in
1-pint (473 mL) amber plastic bottles with child-resistant dispensing closures,
NDC 64778-0244-1.


Store at USP Controlled Room Temperature (20°C - 25°C (68°F - 77°F)).

Other

Rx Only.Keep out of reach of children.Revised: April 2019Manufactured for and distributed by:AMD Medicom Inc. 2555 Chemin de l'AviationPointe-Claire, Montreal, Quebec, Canada H9P 2Z2

* Please review the disclaimer below.