QCare Rx Oral Cleansing and Suctioning System, Q4

• Aids in the removal of secretions and debris.

• Aids in the removal of dental plaque, debris and secretions.

• Aids in the removal of secretions from the oropharyngeal cavity only.

• Sore mouth symptoms do not improve in 7 days.
• Swelling, rash or fever develops.
• Irritation, pain or redness persists or worsens.

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.

• Before opening, turn package over, burst solution packet with thumbs.
• Peel lid to open.
• Remove Mouth Moisturizer and Applicator Swab.
• Attach Suction Swab to Suction Handle.
• Clean teeth and oral cavity for approximately one minute.
• To suction, slide switch to ON. When finished, return switch to OFF.
• To clear tubing, rinse with sterile saline or appropriate solution.
• Discard Suction Swab. Reattach Covered Yankauer to Suction Handle.
• 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.

• Peel lid to open.
• Remove Suction Toothbrush and attach to Suction Handle.
• 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 Handle.
• 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.

• Peel lid to open.
• Attach Suction Catheter to Suction Handle.
• Suction secretions from the oropharyngeal cavity.
• To suction, slide switch to ON. When finished, return switch to OFF.
• To clear tubing, rinse with sterile saline or appropriate solution.
• Discard Suction Catheter. Reattach Covered Yankauer to Suction Handle.
• 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-sterile

• Federal (U.S.A.) law restricts this device to sale by or on the order of a physician or licensed practitioner.

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

Call toll-free 800–323–2220

Manufactured for Sage Products LLC Cary, IL

CHLORHEXIDINE GLUCONATE ORAL RINSE, 0.12%

Rx Only

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:

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.

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.

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.

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.

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.

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.

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].

Keep out of reach of children

Manufactured for:
Sage Products LLC
Cary, IL 60013

1-800-323-2220

Revised: September, 2013

SAGE15ORBTLLBLB

Q·Care^® Rx Oral Cleansing and Suctioning System

Q-Care^® Rx Oral Cleansing and Suctioning System, q4°

Chlorhexidine Gluconate 0.12% Label

Chlorhexidine Gluconate 0.12% Insert