IONITE APF- sodium fluoride gel

Ionite APF by

Drug Labeling and Warnings

Ionite APF by is a Prescription medication manufactured, distributed, or labeled by Dharma Research, inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STORAGE AND HANDLING

• 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

Citric Acid, FDandC 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

• 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

• 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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

IONITE APF 
sodium fluoride gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 53045-200
Route of Administration	DENTAL, TOPICAL, ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	10.241 g  in 490 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XYLITOL (UNII: VCQ006KQ1E)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
PHOSPHORIC ACID (UNII: E4GA8884NN)
HYDROFLUORIC ACID (UNII: RGL5YE86CZ)

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53045-200-17	490 g in 1 BOTTLE
2	NDC: 53045-200-08	245 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/01/2013

Labeler - Dharma Research, inc. (078444642)

Registrant - Dharma Research, inc. (078444642)

Establishment
Name	Address	ID/FEI	Business Operations
Dharma Research, inc.		078444642	manufacture(53045-200)