Active Ingredient(S)
Sodium Fluoride 0.05% (0.02% w/v fluoride ion)............Anticavity
X-pur Opti-rinse Plus
FDA Label NDC 81359-112
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Oral Science Inc for the product X-pur Opti-rinse Plus (NDC 81359-112). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient(s), purpose, use, warnings, otc - stop use, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anticavity
Use
aids in the prevention of dental cavities.
Warnings
Keep out of the reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away
Stop use and ask a doctor or dentist if symptoms persist or condition worsens after regular use
Otc - Stop Use
Stop use and ask a doctor or dentist if symptoms persist or condition worsens after regular use
Otc - Keep Out Of Reach Of Children
If more than used for rinsing is accidently swallowed, get medical help or contact a Poison Control Center right away
Directions
- Adults and children 6 years and older:
- Children 6 years and under
Use once a day after brushing your teeth with a toothpaste
Remove cap
Pour 10 milliliters into a cap (10 mL mark on the inside of cap); do not fill above 10 mL mark Vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out
Do not swallow the rinse
Do not eat or drink for 30 minutes after rinsing
Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing)
Supervise children as necessary until capable of using without supervision
Consult a dentist or doctor
Inactive Ingredients
Purified water, xylitol, glycerin, poloxamer 407, grape flavor, sodium phosphate, bioflavonoids, benzoic acid, cetylpyridinium chloride, mint flavor, red 40
Other Safety Information
store at room temperature (59-86°F) do not use if safety seal is broken or missing
Package Label - Principal Display Panel
500 mL NDC: 81359-112-11
* Please review the disclaimer below.
