Scotts Select Apf Foam Fluoride
FDA Label NDC 69638-066

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Scott's Dental Supply Llc for the product Scotts Select Apf Foam Fluoride (NDC 69638-066). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, description, use, warnings, directions, other information, inactive ingredients, principal display panel - 130 ml bottle label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Drug Facts

STRAWBERRY

Shake well before each use

INVERT CAN COMPLETELY AND DEPRESS NOZZLE TO DISPENSE

Image (Strawberry 01)

Image (Strawberry 01)

Mfg for: Scott's Dental Supply
Fife, WA 98424
1-800-901-3368
WWW.SCOTTSDENTAL.COM

Rx Only
USA
Rev. A Date: 07/25/2016

Description

Active IngredientPurpose
1.23% Fluoride IonFluoride Treatment Foam

Use

This is a prescription fluoride treatment foam used to help prevent dental decay.

Warnings

  • Keep out of reach of children.
  • Do not swallow.
  • Contents under pressure.
  • Do not place in hot water or near radiators, stoves or other sources of heat.
  • Do not puncture or incinerate container. Do not spray toward open flame.
  • For professional use only.

Directions

  • Remove cap from can. Prior to each use, shake can thoroughly for at least 15 seconds.
  • To dispense, invert the can completely upside down. Slowly depress nozzle to dispense foam into a fluoride tray (foam will expand slightly higher than fluoride tray).
  • Air dry teeth thoroughly and insert tray(s) into patient's mouth. Instruct patient to bite down and leave the tray in contact with the teeth between 1 - 4 minutes.
  • Use a saliva ejector during treatment to minimize ingestion of product.
  • Remove tray(s) and have patient expectorate.
  • Instruct patient not to eat, drink or rinse for 30 minutes after treatment.

Other Information

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

Inactive Ingredients

Caster Oil, Decyl Glucoside, Distilled Water, Flavor, Hydrofluoric Acid, Phosphoric Acid, Poloxamer, Propellant A31, Sodium Benzoate, Sodium Laureth Sulfate, Sodium Saccharine, Triethanolamine, Xylitol.

Principal Display Panel - 130 Ml Bottle Label

NDC 69638-066-44

Scott's
SELECT

APF FOAM
With Xylitol

Acidulated Phosphate
Fluoride Treatment Foam

1.23% Fluoride Ion

1 minute or 4
minute treatment

4.4 fl. oz. (130mL)

REORDER 245-2611

GLUTEN FREE
SCOTT'S SELECT

SATISFACTION
Quality
GUARANTEED

Principal Display Panel (130 mL Bottle Label)

Principal Display Panel (130 mL Bottle Label)

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