Dosing & Uses
Dosage Forms & Strengths
oral rinse
- 8 oz bottle with dose cup
Contents
- Purified water, glycerin, benzyl alcohol, sodium saccharin, Carbomer Homopolymer A, potassium hydroxide, citric acid, polysorbate 60, and phosphoric acid
Oral Sores or Irritation
Indicated for the management of oral mucositis/stomatitis that may be caused by radiotherapy and/or chemotherapy and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers (eg, caused by oral surgery, ill-fitting dentures, or braces)
5 mL in mouth and rinse entire oral cavity for a minute or longer
If needed, up to 10 mL may be used to fully coat the inside of the mouth
After rinsing, excess rinse may be expelled or swallowed
Oral mucositis/stomatitis: Use 4-6 times/day
Other ulcerative oral cavity conditions: Use 4-6 times/day or prn
Also see Administration
Safety and efficacy not established
Adverse Effects
None reported
Warnings
Contraindications
Known hypersensitivity to any of the ingredients (see Dosage Forms and Strengths)
Cautions
Good oral hygiene, especially as recommended by a physician, should be used in addition to the use of oral mucoadhesives
Pregnancy & Lactation
Pregnancy Category: C
Lactation: Not systemically absorbed; not distributed into breast milk
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Formulated to adhere to the mucosal surface of the mouth and thereby forms a soothing, protective layer
Administration
Directions for Use
Gently pour 5 mL of rinse into the mouth and rinse the entire oral cavity for a minute or longer if possible
If the action of rinsing is inconvenient or too painful, can be spread throughout the mouth by a gentle rotating action of the head
Ensure that all parts of the oral cavity have been coated with the rinse
If necessary, up to 10 mL may be used to fully coat the inside of the mouth
After rinsing, excess rinse may be expelled or swallowed
Oral mucositis/stomatitis: Use 4-6 times/day; purchase rinse prior to the commencement of cancer therapy
Other ulcerative conditions of the oral cavity: Use 4-6 times/day or prn
Use in addition to good oral care
Special precautions
- Avoid eating or drinking for at least 1 hr after rinsing
- After use, replace the bottle cap and tightly seal the bottle
- Do not use this product after the expiration date shown on the product label
- Do not use this product in patients with a known sensitivity to any of product’s ingredients
- Dilution of the product prior to use is not recommended
Storage
Store at room temperature out of direct sunlight
Images
Formulary
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Adding plans allows you to:
- View the formulary and any restrictions for each plan.
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