Aquawhite Red Gel Cavity Fightingtooth
FDA Label NDC 72025-003

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Jhs Svendgaard Laboratories Limited for the product Aquawhite Red Gel Cavity Fightingtooth (NDC 72025-003). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient

Sodium Monofluorophosphate 0.76%

Otc - Purpose

Purpose:

Anticavity

Indications & Usage

Uses:

Helps protect  against cavities

Warnings

Warnings:

If you accidentally swallow more than used for brushing, seek professional help 

Otc - Keep Out Of Reach Of Children

Keep out of reach of children under 6 years of age

Dosage & Administration

Directions:

  • Adults and children 2 years and older:
  • Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist.
  • Do not swallow
  • Children under 6 Years of Age
    • To minimize swallowing use a pea-sized amount and supervise children's brushing untill good habits are established.

      • Children under 2 years of age:

      • Ask a dentist or physician

Inactive Ingredient

Inactive Ingredients:

Sorbitor, Water, Silica, Glycerin, Sodium Lauryl Suphate, Flavor, PEG-1500, Sodium Carboxymethylcellulose, Xylitol, Xanthan Gum, Sodium Methyl Paraben, Sodium Phosphate, Sodium Propyl Paraben, Sodium Saccharin, Cooling Crystal, FD&C Red 40

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