PURELIFE APF- sodium fluoride gel 
PureLife 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 Ingredient

Fluoride Ion 1.23%.

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 or four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment twice a year.

1. After thorough prophylaxis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth.

2. Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness).

3. 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, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol. May contain blue #1, green #3, red #3, red #40, yellow #5 (tartrazine), as a color additive.

Purelife_APF_gel.jpg

PURELIFE APF 
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68987-012
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)  
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
XYLITOL (UNII: VCQ006KQ1E)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Product Characteristics
ColorpurpleScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68987-012-15454 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/18/2012
Labeler - PureLife Dental (828690904)

Revised: 1/2022
Document Id: d5f3e776-11ac-7413-e053-2995a90a4603
Set id: 615840e4-c108-4d68-b815-fc95ae75539c
Version: 4
Effective Time: 20220119
 
PureLife Dental