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:

• A stable thixotropic fluoride treatment gel used to help prevent dental decay.
• For Professional Office Use Only. This product is not intended for home or unsupervised consumer use.

Warnings:

• Keep out of 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.
• Read directions carefully before using.

Dosage and administration:

Other information:

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

Inactive Ingredients:

Citric Acid, FD&C Red #40, FD&C Yellow #5 (tartrazine) as a color additive, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol

Benco_APF_orange.jpg

IRIS 60 SECOND APF 
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66975-053
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)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Product Characteristics
ColororangeScore    
ShapeSize
FlavorORANGE (Orange Smoothie) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66975-053-15454 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: d70c7b9f-7d80-51ac-e053-2995a90a4a8f
Set id: 8f5d420b-3348-4002-9a09-b05e8cbb35c9
Version: 3
Effective Time: 20220202
 
Benco Dental