Indications and uses
A stable thixotropic fluoride treatment gel used to help prevent dental decay. For Professional Use Only. This product is not intended for home or unsupervised use.
60 Second Fluoride Gel
- Manufacturer
- Darby Dental Supply, LLC
- Effective date
- 2022-01-24
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-05-31 20:39:40
Label at a glance#
Product60 Second Fluoride Gel
Active ingredientSODIUM FLUORIDE
Label structure8 sections
Dosage and administration
Shake well before use. This is a one minute or four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment two times a year. 1. After thorough prophylaxsis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth. 2. Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100...
Storage and handling
Do not store 25°C/77°F. Do not freeze.
Label contents#
Full prescribing information#
Active Ingredient:
Fluoride Ion 1.23%
Available from 2.09% Sodium Fluoride and Hydrofluoric Acid
Purpose:
Fluoride Treatment Gel
Indications and Usage:
- A stable thixotropic fluoride treatment gel used to help prevent dental decay.
- For Professional Use Only. This product is not intended for home or unsupervised use.
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.
Dosage and Administration:
Shake well before use. This is a one minute or four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment two times a year.
1. After thorough prophylaxsis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth.
2. Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness).
3. Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.
Other Information:
Do not store 25°C/77°F. Do not freeze.
Inactive Ingredients:
Citric Acid, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol. May contain Blue #1, Green #3, Red #3, Red #40, Yellow #5 (tartazine). Yellow #6 as a color additive.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 66467-2210-1 | 60 Second Fluoride Gel | 454 g in 1 BOTTLE, PLASTIC | GEL | 454 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 66467-2210 | 60 SECOND FLUORIDE GEL (SODIUM FLUORIDE) GEL [DARBY DENTAL SUPPLY, LLC] | 3 | Current NDC, Legacy NDC, 1 package rows | 20220125_90a2e268-bee8-498d-e053-2995a90ad52b.zip |
Products#
Every source-derived product name is available through these pages.
- 60 Second Fluoride Gel
- Sodium Fluoride
- CITRIC ACID MONOHYDRATE
- MAGNESIUM ALUMINUM SILICATE
- PHOSPHORIC ACID
- POLYSORBATE 20
- SODIUM BENZOATE
- SACCHARIN SODIUM
- WATER
- XANTHAN GUM
- XYLITOL
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
- FD&C YELLOW NO. 5
- FD&C RED NO. 3
- FD&C GREEN NO. 3
- FD&C BLUE NO. 1
- TITANIUM DIOXIDE
- FLUORIDE ION
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 66467-2210 | 66467-2210-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 60 Second Fluoride Gel | SODIUM FLUORIDE | Darby Dental Supply, LLC | 90a2e268-bee8-498d-e053-2995a90ad52b | 2022-01-24 | Warnings | 66467-2210-1 66467-2210 66467221001 d65b1aed-c93b-46df-e053-2a95a90ad44d 90a2e268-bee8-498d-e053-2995a90ad52b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.