Primo APF

PRIMO APF- sodium fluoride gel
Tri State 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.

Fluoride Ion 1.23%

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 Use Only. This product is not intended for home or unsupervised 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:

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 two times a year.

1. After thorough prophylaxsis, 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:

Store at controlled room temperature 59° to 86°F (15°-30°C).

Protect from freezing.

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.

TSPRIMOAPFOV
(click image for full-size original)

PRIMO APF
sodium fluoride gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69509-058
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 5.6 g in 454 g
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
MAGNESIUM ALUMINUM SILICATE
PHOSPHORIC ACID
POLYSORBATE 20
SODIUM BENZOATE
SACCHARIN SODIUM
WATER
XANTHAN GUM
XYLITOL
FD&C RED NO. 40
FD&C YELLOW NO. 5
TITANIUM DIOXIDE
Product Characteristics
Color orange Score
Shape Size
Flavor ORANGE, VANILLA Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69509-058-15 454 g in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/01/2013
Labeler — Tri State Dental (176048478)

Revised: 01/2022 Tri State Dental

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