Scotts Select Neutral Apf Fluoride
FDA Label NDC 69638-157

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 Neutral Apf Fluoride (NDC 69638-157). 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 - 500 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

With Xylitol & Vitamin E

Neutral PH Phosphate Fluoride Treatment Gel 2% Sodium Fluoride

Mfg for
Scott's
Dental Supply®
Fife, WA 98424
1-800-901-3368
www.SCOTTSDENTAL.com

Rx ONLY
USA
Rev. A Date: 02/25/2020

Description

Active IngredientPurpose
Sodium Fluoride 2%Anticaries

Use

Prescription fluoride treatment gel used to prevent dental decay.

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 immediately.
  • Do not use on patients with an allergy to fluoride.
  • Scott's APF Gel contains artificial color, confirm that no known patient allergies exist.
  • For professional use only.

Directions

  • Shake well before use.
  • This is a four minute fluoride gel for in-office patient use.
  • For best results, use at least 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 four minutes.
  • Remove trays, instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.

Other Information

  • Store at 59° –86°F (15°–30°C).
  • Protect from freezing.
  • Scott's APF Gel is free of gluten, soy, milk, egg, peanut and tree nut products.

Inactive Ingredients

Citric Acid, FD&C Green No. 3 (C.I. 42053), FD&C Yellow No. 5 (C.I. 19140), Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Potassium Hydroxide, Purified Water, Sodium Benzoate, Sodium Saccharin, Sweetness Enhancer, Titanium Dioxide, Tocopheryl Acetate, Xantham Gum, Xylitol.

Principal Display Panel - 500 Ml Bottle Label

NDC 69638-157-16

Scott's
✓SELECT

NEUTRAL APF GEL
Thixotropic
4 minute treatment

MINT
17 fl. oz. (500mL)

REORDER 245-2006

GLUTEN FREE
SCOTT'S SELECT

SATISFACTION
Quality
GUARANTEED

Principal Display Panel (500 mL Bottle Label)

Principal Display Panel (500 mL Bottle Label)

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