Dental Clear Premium
FDA Label NDC 24765-127

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pharmacal-international. Co., Ltd. for the product Dental Clear Premium (NDC 24765-127). 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 active ingredient, purpose, use, directions, warnings, inactive ingredients, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Sodium Fluoride (0.02%)

Purpose

  • Anticavity mouthwash

Use

  • Aids in prevention of dental cavities

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.

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.

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

Image 1 (Label)

Image 1 (Label)

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