SPL v3
SPL
SPL Set ID bc9664df-c4eb-4d29-b1c0-4d4dff6a75e4
Routes
DENTAL ORAL
Published
Effective Date 2020-11-16
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (6.027 g)
Inactive Ingredients
Citric Acid Monohydrate Fd&c Red No. 40 Magnesium Aluminum Silicate Phosphoric Acid Polysorbate 20 Water Sodium Benzoate Saccharin Sodium Titanium Dioxide .alpha.-tocopherol Acetate, Dl- Xanthan Gum Xylitol

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2013-01-01
Description

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

Medication Information

Description

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

Section 43685-7
  • 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.

Section 44425-7
  • Store at 59o - 86oF (15o - 30oC)
  • Protect from freezing
  • Ionite APF Gel is free of gluten, soymilk, egg peanut and free of nut products
Section 51727-6



Citric Acid, FD & C Red No. 40 (C.I. 16035), Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Purified Water, Sodium Benzoate, Sodium Saccharin, Sweetness Enhancer, Titanium Dioxide, Tocopheryl Acetate, Xanthan Gum, Xylitol

Section 51945-4

Section 59845-8
  • 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

Structured Label Content

Section 43685-7 (43685-7)
  • 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.

Section 44425-7 (44425-7)
  • Store at 59o - 86oF (15o - 30oC)
  • Protect from freezing
  • Ionite APF Gel is free of gluten, soymilk, egg peanut and free of nut products
Section 51727-6 (51727-6)



Citric Acid, FD & C Red No. 40 (C.I. 16035), Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Purified Water, Sodium Benzoate, Sodium Saccharin, Sweetness Enhancer, Titanium Dioxide, Tocopheryl Acetate, Xanthan Gum, Xylitol

Section 51945-4 (51945-4)

Section 59845-8 (59845-8)
  • 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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:35:37.262378 · Updated: 2026-03-14T21:43:53.176157