Ology Fluoride
FDA Label NDC 0363-2008

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Ology Fluoride (NDC 0363-2008). 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 ingredients, uses, directions, inactive ingredients, warnings, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Sodium monofluorophosphate 0.76%................Anticavity (0.15% w/v fluoride ion)

Uses

  • Helps protect against cavitites.
    • Helps protect against cavitites.

Directions

  • adults and children 12 years and older: brush teeth thoroughly, preferably after each meal, or at least twice a day, or as directed by your dentist.  do not swallow.
  • children under 6 years of age: to minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established.
  • children under 2 years of age: ask a dentist or physician.

Inactive Ingredients

glycerin, water, calcium carbonate, hydrated silica, xylitol, cellulose gum, cocamidopropyl betaine, flavour peppermint oil, sodium bicarbonate, zinc citrate, sucralose.

Warnings

as with all fluoride toothpastes, keep out of reach of children under 6 years of age.  If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.

* Please review the disclaimer below.