Storage and handling
Store at 59 o - 86 o F (15 o - 30 o C) Protect from freezing Ionite APF Gel is free of gluten, soymilk, egg peanut and free of nut products
Ionite APF
- Manufacturer
- Dharma Research, Inc.
- Effective date
- 2021-02-20
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 20:35:38
Label at a glance#
ProductIonite APF
Active ingredientSODIUM FLUORIDE
Label structure5 sections
Label contents#
Full prescribing information#
STORAGE AND HANDLING SECTION
- Store at 59o - 86oF (15o - 30oC)
- Protect from freezing
- Ionite APF Gel is free of gluten, soymilk, egg peanut and free of nut products
INACTIVE INGREDIENT SECTION
Citric Acid, F D & C Red No. 40 (C.I. 16035), Flavor, Hydrofluoric Acid, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Purified Water, Sodium Benzoate, Sodium Saccharin, Sweetness Enhancer, Titanium Dioxide, Tocopheryl Acetate, Xanthan Gum, Xylitol.
WARNINGS AND PRECAUTIONS SECTION
- Keep out of the 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.
- Do not use on patients with an allergy Fluoride.
- Ionite APF Gel contains artificial color, confirm that no kno.wn patient allergies exist.
- For professional use only.
INSTRUCTIONS FOR USE SECTION
- Shake well before use.
- This is a four minute or one minute Fluoride gel for in-office patient use.
- For best results, use at least 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
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53045-205-17 | 2021-02-22 | C162847 | 48780-1 | 9d75b9d0-940c-f424-e053-dadaa90a57ce | ab9b07ad-f6b2-4289-bec4-fec58270dc97 |
| 53045-205-17 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-940c-f424-e053-dadaa90a57ce | ab9b07ad-f6b2-4289-bec4-fec58270dc97 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53045-205-17 | Ionite APF | 490 g in 1 BOTTLE | GEL | 490 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Ionite APF
- Sodium Fluoride
- FLUORIDE ION
- WATER
- MAGNESIUM ALUMINUM SILICATE
- FD&C RED NO. 40
- SACCHARIN SODIUM
- SODIUM BENZOATE
- TITANIUM DIOXIDE
- XYLITOL
- ANHYDROUS CITRIC ACID
- .ALPHA.-TOCOPHEROL ACETATE
- XANTHAN GUM
- CARBOMER HOMOPOLYMER TYPE C
- PHOSPHORIC ACID
- HYDROFLUORIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 53045-205 | 53045-205-17 |
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 |
|---|---|---|---|---|---|---|
| Ionite APF | SODIUM FLUORIDE | Dharma Research, Inc. | ab9b07ad-f6b2-4289-bec4-fec58270dc97 | 2021-02-20 | Warnings | 53045-205-17 53045-205 53045020517 dd3dc685-7167-463c-8752-aa9f2ac2dad3 ab9b07ad-f6b2-4289-bec4-fec58270dc97 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.