SPL v3
SPL
SPL Set ID ad7a660b-274c-417e-bdf3-1d5addf06ad1
Routes
DENTAL ORAL
Published
Effective Date 2020-11-18
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (4.41 g)
Inactive Ingredients
Citric Acid Monohydrate Fd&c Green No. 3 Fd&c Yellow No. 5 Magnesium Aluminum Silicate Phosphoric Acid Polysorbate 20 Potassium Hydroxide 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 Neutral Gel contains artificial color, confirm that no known 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 Green No. 3 (C.I. 42053), FD & C Yellow No. 5 (C.I. 19140), Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Potassium Hydroxide, Purified Water, Sodium Benzoate, Sodium Saccharin, Sweetness Enhancer, Titanium Dioxide, Tocopheryl Acetate, Xantham 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 Neutral Gel contains artificial color, confirm that no known 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 Green No. 3 (C.I. 42053), FD & C Yellow No. 5 (C.I. 19140), Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Potassium Hydroxide, Purified Water, Sodium Benzoate, Sodium Saccharin, Sweetness Enhancer, Titanium Dioxide, Tocopheryl Acetate, Xantham 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

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