Prescribing information (package insert) - 60-second Fluoride
INDICATIONS
For topical application to aid in the protection against dental caries.
CONTAINS
Fluoride (Sodium Fluoride) – 1.23% w/w.
DOSAGE & ADMINISTRATION
Fill fluoride tray with 2-3ml of fluoride gel per arch. Dry tooth surface and insert tray(s) in mouth. Have patient bite down for 60 seconds (or up to 4 minutes). Slight chewing motion provides interproximal coverage. Remove tray(s) and have patient expectorate excess gel. Inform patient not to eat, drink or rinse for 30 minutes.
CAUTION
For Professional Office use only. This product is not intended for home or unsupervised consumer use.
WARNING
Keep out of reach of children. If more than is used for a fluoride application is swallowed, get medical help or contact a Poison Control Center right away.
Store at controlled room temperature:
68-77°F (20-25°C). Prevent from freezing.
Shake well before each use.
About this document
Source: FDA drug labeling via NLM DailyMed
· View the label on DailyMed
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Drug information for 60-second Fluoride
| Rx or OTC |
Prescription (Rx)?
- This drug is available only with a prescription from a licensed healthcare provider.
- Rx
|
| Active ingredient |
Sodium fluoride 12.3 mg/g
|
| Dosage form |
Gel |
| Route |
Dental |
| Marketing status |
not in the current FDA NDC Directory |
| Company (applicant) |
Patterson Dental Supply Inc |
| FDA approval |
UNAPPROVED DRUG OTHERUnapproved drug
|
| Manufacturers |
1 labelers list this drug on DailyMed |
| Packages (NDC) |
| Package |
|
12.3 mg/g – 454 g in 1 bottle, plastic
NDC 50227-3221-6
|
|
12.3 mg/g – 454 g in 1 bottle, plastic
NDC 50227-3231-6
|
|
12.3 mg/g – 454 g in 1 bottle, plastic
NDC 50227-3251-6
|
|
12.3 mg/g – 454 g in 1 bottle, plastic
NDC 50227-3281-6
|
|
12.3 mg/g – 454 g in 1 bottle, plastic
NDC 50227-3271-6
|
|
12.3 mg/g – 454 g in 1 bottle, plastic
NDC 50227-3261-6
|
|
12.3 mg/g – 454 g in 1 bottle, plastic
NDC 50227-3211-6
|
|
12.3 mg/g – 454 g in 1 bottle, plastic
NDC 50227-3241-6
|
|
Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.
