Recommended Use:
For topical application to aid in the prevention of dental caries.
Neutrarinse 2% Neutral Sodium Floride Oral Rinse Raspberry Splash
FDA Label NDC 61508-0528
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Germiphene Corporation for the product Neutrarinse 2% Neutral Sodium Floride Oral Rinse Raspberry Splash (NDC 61508-0528). 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 recommended use:, otc - purpose, medicinal ingredient:, non-medicinal ingredients:, directions:, warning:, otc - keep out of reach of children, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Neutral pH makes Neutrarinse especially safe for crowns and restorations.
Medicinal Ingredient:
2.0% Neutral sodium fluoride
Non-Medicinal Ingredients:
Water, sodium phosphate dibasic, parabens, sorbitol, xylitol, sodium saccharin, ethanol, povidone, and flavouring agents.
Directions:
Dispense up to 10 mL of Neutrarinse 2% Neutral Sodium Fluoride Solution into a measuring cup. Instruct patient to rinse vigorously for one minute with up to 10 mL of the solution arond and between teeth, then expectorate. DO NOT SWALLOW. Instruct patient not to eat, drink, or rinse mouth for at least 30 minutes.
Neutrarinse 2% Neutral Sodium Fluoride Solution may also be applied full strength with cotton pledgets, to teeth isolated with cotton rolls.
Warning:
The product is intended for topical use only, not for internal use. Not recommended for use by children under 6 years of age.
Instruct patient not to eat, drink, or rinse mouth for at least 30 minutes. Do not use if tamper-evident seal is broken. Do not store in direct sunlight.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Package Label.Principal Display Panel
White Grape (Nrgr 2)
Refreshmint (Nrmt 2)
Raspberry Splash (Nrvb 2)
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