NDC 53462-592 Oral Cleansing And Suctioning System, Q2

NDC Product Code 53462-592

NDC 53462-592-16

Package Description: 1 KIT in 1 KIT * 7 mL in 1 POUCH * 28 mL in 1 POUCH * 15 mL in 1 BOTTLE * 2 g in 1 POUCH

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Oral Cleansing And Suctioning System, Q2 with NDC 53462-592 is a product labeled by Sage Products Llc. The generic name of Oral Cleansing And Suctioning System, Q2 is . The product's dosage form is and is administered via form.

Labeler Name: Sage Products Llc

Dosage Form: -

Product Type: 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.

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.

  • WATER (UNII: 059QF0KO0R)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • PHOSPHORIC ACID (UNII: E4GA8884NN)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PEG-40 SORBITAN DIISOSTEARATE (UNII: JL4CCU7I1G)
  • ALCOHOL (UNII: 3K9958V90M)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • WATER (UNII: 059QF0KO0R)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Labeler Information

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

Labeler Name: Sage Products Llc
Labeler Code: 53462
Start Marketing Date: 07-01-2014 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: 12-31-2017 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: I 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.

Oral Cleansing And Suctioning System, Q2 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

Drug Facts

Suction Swab with Perox-A-Mint SolutionActive Ingredient: PEROX-A-MINT:PurposeHydrogen Peroxide 1.5%Oral Debriding AgentSuction Toothbrush CHG compatible**Compatible for use with 0.12%
Chlorhexidine Gluconate (CHG) oral rinse, tested for use up to five
minutes.NOTE: The following
Uses and Directions refer to the Suction Toothbrush and Swab. For
Warnings, Uses and Directions specific to the CHG rinse including
use in children under 18 years of age, refer to that product’s package
insert and labeling.

Uses

  • Suction Swab with Perox-A-Mint SolutionAids in the removal of secretions and debris.Suction Toothbrush CHG compatible*Aids in the removal of dental plaque, debris and secretions.Suction Swab with Alcohol-Free MouthwashAids in the removal of debris.Helps the mouth feel fresh and clean.Helps temporarily reduce dryness.Oropharyngeal Suction Catheter Non-sterileAids in the removal of secretions from the oropharyngeal
  • Cavity only.

Warnings

  • Stop use and ask a doctor if:Sore mouth symptoms do not improve in 7 days.Swelling, rash or fever develops.Irritation, pain or redness persists or worsens.

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.

Otc - Keep Out Of Reach Of Children

Keep out of
reach of children.If more than used for debriding
is accidentally swallowed, get medical help or contact a Poison Control
Center right away.

Directions

  • Suction Swab with Perox-A-Mint SolutionBefore opening, turn package over, burst solution
  • Packet with thumbs.Peel lid to open.Remove Mouth Moisturizer and Applicator Swab.Attach Suction Swab to suction line.Clean teeth and oral cavity for approximately one minute.To suction, place thumb over port.To clear tubing, rinse with sterile saline or appropriate
  • Solution.Discard Suction Swab. Reattach Covered Yankauer to suction
  • Line.Place Mouth Moisturizer on Applicator Swab.Apply as needed to lips and inside mouth.Use up to 4 times daily or as directed by a dentist or doctor.Children under 12 years of age: supervise use.Children under 3 years of age: consult a dentist or doctor.Use a bite block when performing oral care on patients with
  • Altered levels of consciousness or those who cannot comprehend commands.Ensure foam is intact after use. If not, remove any particles
  • From oral cavity.Suction Toothbrush CHG compatible*Peel lid to open.Remove Suction Toothbrush and attach to suction line.When using with a cleansing solution, refer to the product
  • Packaging for indications, instructions and warnings.To suction, place thumb over port.To clear tubing, rinse with sterile saline or appropriate
  • Solution.Discard Suction Toothbrush. Reattach Covered Yankauer to
  • Suction line.Use Swab for additional cleansing as needed.Use two times daily or as directed by a dentist or doctor.Children under 12 years of age: supervise use.Children under 3 years of age: consult a dentist or doctor.Use a bite block when performing oral care on patients with
  • Altered levels of consciousness or those who cannot comprehend commands.Ensure foam is intact after use. If not, remove any particles
  • From oral cavity.Suction Swab with Alcohol-Free MouthwashBefore opening, turn package over, burst solution
  • Packet with thumbs.Peel lid to open.Remove Mouth Moisturizer and Applicator Swab.Attach Suction Swab to suction line.Clean teeth and oral cavity.To suction, place thumb over port.To clear tubing, rinse with sterile saline or appropriate
  • Solution.Discard Suction Swab. Reattach covered Yankauer to suction
  • Line.Place Mouth Moisturizer on Applicator Swab.Apply as needed to lips and inside mouth.Children under 12 years of age: supervise use.Use a bite block when performing oral care on patients with
  • Altered levels of consciousness or those who cannot comprehend commands.Ensure foam is intact after use. If not, remove any particles
  • From oral cavity.Oropharyngeal Suction Catheter Non-sterileAttach Suction Catheter to suction line.Suction secretions from the oropharyngeal cavity.To suction, place thumb over port.To clear tubing, rinse with sterile saline or appropriate
  • Solution.Discard Suction Catheter. Reattach Covered Yankauer to suction
  • Line.Use a bite block when performing oral care on patients with
  • Altered levels of consciousness or those who cannot comprehend commands.Oropharyngeal Suction
  • Catheter Non-sterileCautionFederal (U.S.A.) law restricts this device to sale by or
  • On the order of a physician or licensed practitioner.

Inactive Ingredients

Suction Swab with
Perox-A-Mint Solution Water, menthol flavor, polysorbate
80, phosphoric acid, sodium saccharin, Blue 1 (CI 42090), Yellow 6
(CI 15985)

Questions?

Call toll-free 800-323-2220Manufactured for Sage Products LLC Cary,
IL

Other

CHLORHEXIDINE GLUCONATE ORAL RINSE, 0.12%Rx Only

Keep out of reach of childrenManufactured for:Sage
Products LLCCary, IL 600131-800-323-2220Revised: September, 2013SAGE15ORBTLLBLB

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&C Blue No. 1. Chlorhexidine Gluconate
is a near-neutral solution (pH range 5-7). Chlorhexidine Gluconate
is a salt of chlorhexidine and gluconic acid. Its chemical structure
is:

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 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 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 than 1% of the chlorhexidine
gluconate ingested by these subjects was excreted in the urine.

Indications And Usage

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

Chlorhexidine Gluconate Oral Rinse should not
be used by persons who are known to be hypersensitive to chlorhexidine
gluconate or other formula ingredients.

General

  • 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.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 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.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 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 the
age of 18.

Carcinogenesis, Mutagenesis, 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

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 1.0%. 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

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

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.

How Supplied

Chlorhexidine Gluconate Oral Rinse
is supplied as a blue liquid in single dose 0.5 fluid ounce (15mL)
amber plastic bottles with child-resistant dispensing closures. 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].

* Please review the disclaimer below.