IRIS 60 SECOND APF- sodium fluoride gel 
Benco Dental

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Active Ingredients:

1.23% Fluoride Ion

Available from 2.09% Sodium Fluoride and Hydrofluoric Acid.

Purpose:

Fluoride Treatment Gel

Indications and usage:

Warnings:

Dosage and administration:

Shake well before use. This is a one minute of four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment 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.

Other information:

Do not store above 25°C/77°F. Do not freeze.

Inactive Ingredients:

Citric Acid, FD&C Red #40, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol.

Benco_APF_bubble.jpg

IRIS 60 SECOND APF 
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66975-050
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION5.6 g  in 454 g
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
XYLITOL (UNII: VCQ006KQ1E)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66975-050-15454 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/14/2012
Labeler - Benco Dental (015108087)

Revised: 2/2022
Document Id: d70c50cf-7e92-15be-e053-2a95a90a0713
Set id: 5fa57e34-5827-4d37-a5dc-965750e5be50
Version: 5
Effective Time: 20220202
 
Benco Dental