Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID 7377dcfa-c584-4360-81ce-6c46387e1454
Route
ORAL
Published
Effective Date 2020-03-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.2 mg)
Inactive Ingredients
Water Glycerin Allantoin Acetic Acid Xylitol Sodium Acetate Sodium Benzoate Green Tea Leaf Malic Acid Racementhol Saccharin Sodium Anhydrous Lemon Oil

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2020-03-14
Description

Sodium Fluoride (0.02%)

Purpose

Anticavity mouthwash

Medication Information

Purpose
  • Anticavity mouthwash
Description

Sodium Fluoride (0.02%)

Use
  • Aids in prevention of dental cavities
Warnings
  • Keep out of reach of children.
  • Children under 7 years or younger must have parent supervision.
  • Do not swallow. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
Directions
  • Rinse mouth with this Dental Clear Premium about 10~15ml for 30 seconds then expel

Average daily dose

  •  Use twice a day after brushing, meals, and before social occasions.
Active Ingredient

Sodium Fluoride (0.02%)

Inactive Ingredients

Water,,Glycerin,Allantoin,Acetic acid,Xylitol,Sodium acetate,Sodium Benzoate,GreenTea Extract,Malic acid,L-Menthol,Propolis Extract,Citrus flavoring,Lemon flavoring,Sodium Saccharin,Lemon Oil,Cacao Color

Principal Display Panel

Structured Label Content

Use
  • Aids in prevention of dental cavities
Purpose
  • Anticavity mouthwash
Warnings
  • Keep out of reach of children.
  • Children under 7 years or younger must have parent supervision.
  • Do not swallow. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
Directions
  • Rinse mouth with this Dental Clear Premium about 10~15ml for 30 seconds then expel

Average daily dose

  •  Use twice a day after brushing, meals, and before social occasions.
Active Ingredient (Active ingredient)

Sodium Fluoride (0.02%)

Inactive Ingredients

Water,,Glycerin,Allantoin,Acetic acid,Xylitol,Sodium acetate,Sodium Benzoate,GreenTea Extract,Malic acid,L-Menthol,Propolis Extract,Citrus flavoring,Lemon flavoring,Sodium Saccharin,Lemon Oil,Cacao Color

Principal Display Panel (Principal display panel)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:02.009710 · Updated: 2026-03-14T23:04:26.705807