Iris 60 Second APF
Sodium Fluoride · Gel · Dental
Uses
Indications and usage:
• A stable thixotropic fluoride treatment gel used to help prevent dental decay.
• For Professional Office Use Only. This product is not intended for home or unsupervised consumer use.
Dosage and administration
Dosage and administration: Shake well before use. This is a one minute of four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment twice a year.
• After thorough prophylaxis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth.
• Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness).
• Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.
Warnings
Warnings:
• Keep out of reach of children.
• Do not swallow. If product is accidentally swallowed in quantities greater than would normally occur with a treatment gel, seek medical help or contact a Poison Control Center right away.
• Read directions carefully before using.
Storage
Other information: Do not store above 25°C/77°F. Do not freeze.
Label text from the FDA structured product label by Benco Dental (revised Feb 2, 2022). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Sodium Fluoride in 5 products
Iris 60 Second APF NDC products (5)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 66975-050 | Sodium Fluoride 5.6 g/454g Gel | Benco Dental | UNAPPROVED DRUG OTHER |
| 66975-051 | Sodium Fluoride 5.6 g/454g Gel | Benco Dental | UNAPPROVED DRUG OTHER |
| 66975-052 | Sodium Fluoride 5.6 g/454g Gel | Benco Dental | UNAPPROVED DRUG OTHER |
| 66975-053 | Sodium Fluoride 5.6 g/454g Gel | Benco Dental | UNAPPROVED DRUG OTHER |
| 66975-054 | Sodium Fluoride 5.6 g/454g Gel | Benco Dental | UNAPPROVED DRUG OTHER |
Frequently asked questions
What is Iris 60 Second APF used for?
Indications and usage: • A stable thixotropic fluoride treatment gel used to help prevent dental decay. • For Professional Office Use Only. This product is not intended for home or unsupervised consumer use.
Who makes Iris 60 Second APF?
Iris 60 Second APF is listed by 1 labeler in the FDA NDC directory, including Benco Dental.