Pediatric Use
Clinical effectiveness and safety of Chlorhexidine Gluconate Oral Rinse, 0.12% have not been established in children under the 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
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, 0.12% 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, 0.12%.
There have been cases of parotid gland swelling and inflammation of the salivary glands (sialadentis) reported in patients using chlorhexidine gluconate oral rinse.
To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
OVERDOSAGE
Ingestion of 1 or 2 ounces of Chlorhexidine Gluconate Oral Rinse, 0.12% 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, 0.12% is ingested by a small child or if signs of alcohol intoxication develop.
DOSAGE AND ADMINISTRATION
Chlorhexidine Gluconate Oral Rinse, 0.12% therapy should be initiated directly following a dental prophylaxis. Patients using Chlorhexidine Gluconate Oral Rinse, 0.12% 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 1/2 fl oz (marked in cup) of undiluted Chlorhexidine Gluconate Oral Rinse, 0.12%. Patients should be instructed to not rinse with water or other mouthwashes, brush teeth or eat immediately after using Chlorhexidine Gluconate Oral Rinse, 0.12%. Chlorhexidine Gluconate Oral Rinse, 0.12% is not intended for ingestion and should be expectorated after rinsing.
HOW SUPPLIED
Chlorhexidine Gluconate Oral Rinse, 0.12% is a blue, peppermint flavored liquid in:
A 16 fl oz (473 mL) amber plastic bottle with a child-resistant closure and dosage cup for consumer use, and in 15 mL unit dose cups.
It should be dispensed in original container or in amber glass.
Store above freezing 0°C (32°F).
Rx only
Manufactured by:
Hi-Tech
Pharmacal Co., Inc.
Amityville, NY 11701
Rev. 720:00 7/10
MG# 11387
PRINCIPAL DISPLAY PANEL — Kit Carton
HALYARD*
24-HOUR
ORAL CARE KIT
with BALLARD* Technology
Use
with
CHG
▼
CHG
with
H2 O2
q2
1
HALYARD*
Prep
Pack
2
HALYARD*
Toothbrush
Packs
4
HALYARD*
Suction Swab
Packs with H2 O2
6
HALYARD*
Suction Swab Packs
with Alcohol-Free Mouthwash
2
HALYARD*
Suction CatheterPacks
Q2 ORAL CARE KIT WITH CHG hydrogen peroxide and chlorhexidine gluconate kit |
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Part 1 of 4 | HYDROGEN PEROXIDE hydrogen peroxide mouthwash | |
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Part 2 of 4 | ALCOHOL FREE MOUTHWASH inert mouthwash | |
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Part 3 of 4 | MOUTH MOISTURIZER inert unassigned | |
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Part 4 of 4 | CHLORHEXIDINE GLUCONATE chlorhexidine gluconate rinse | |
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Revised: 01/2016 Halyard Health
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https://medlibrary.org/lib/rx/meds/q2-oral-care-kit-with-chg/page/2/