SPL v3
SPL
SPL Set ID ddd34623-cb79-4fa7-bd01-19122470b63d
Routes
DENTAL TOPICAL ORAL
Published
Effective Date 2020-10-27
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.5498 g)
Inactive Ingredients
Castor Oil Decyl Glucoside Water Hydrofluoric Acid Phosphoric Acid Sodium Benzoate Sodium Laureth Sulfate Saccharin Sodium Xylitol Poloxamer 407 Trolamine

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2013-04-22
Description

Castor Oil, Decyl Glucoside, Distilled Water, Flavor, Hydrofluoric Acid, Phosphoric Acid, Poloxamer, Propellant A31, Sodium Benzoate, Sodium Laureth Sulface, Sodium Saccharne, Triethanolamine, Xylitol

Medication Information

Description

Castor Oil, Decyl Glucoside, Distilled Water, Flavor, Hydrofluoric Acid, Phosphoric Acid, Poloxamer, Propellant A31, Sodium Benzoate, Sodium Laureth Sulface, Sodium Saccharne, Triethanolamine, Xylitol

Section 43685-7
  • Do not swallow.
  • Keep out of reach of children.
  • 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 towards open flames.
  • For professional use only.
Section 44425-7

Store at a controlled room temperature 59o-86oF (15o-30oC).

Section 51727-6

Castor Oil, Decyl Glucoside, Distilled Water, Flavor, Hydrofluoric Acid, Phosphoric Acid, Poloxamer, Propellant A31, Sodium Benzoate, Sodium Laureth Sulface, Sodium Saccharne, Triethanolamine, Xylitol

Section 51945-4

Section 59845-8
  • 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 inset 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 the tray(s) and have patient expectorate.
  • Instruct patient not to eat, drink or rinse for 30 minutes after treatment.

Structured Label Content

Section 43685-7 (43685-7)
  • Do not swallow.
  • Keep out of reach of children.
  • 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 towards open flames.
  • For professional use only.
Section 44425-7 (44425-7)

Store at a controlled room temperature 59o-86oF (15o-30oC).

Section 51727-6 (51727-6)

Castor Oil, Decyl Glucoside, Distilled Water, Flavor, Hydrofluoric Acid, Phosphoric Acid, Poloxamer, Propellant A31, Sodium Benzoate, Sodium Laureth Sulface, Sodium Saccharne, Triethanolamine, Xylitol

Section 51945-4 (51945-4)

Section 59845-8 (59845-8)
  • 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 inset 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 the tray(s) and have patient expectorate.
  • Instruct patient not to eat, drink or rinse for 30 minutes after treatment.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:35:34.908852 · Updated: 2026-03-14T21:43:47.347133