Drug Facts
Sodium monofluorophosphate 0.76% (0.1% w/v fluoride ion)
Agtoothpaste
FDA Label NDC 73235-9138
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ag International for the product Agtoothpaste (NDC 73235-9138). 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 drug facts, purpose, use, warning, directions, other information, inactive ingredients, principal display panel - 43 g tube carton, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anticavity Toothpaste
Use
aids in the prevention of dental cavities
Warning
- Keep out of reach of children under 6 years of age
- If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control center immediately
Directions
- Do not swallow
- Supervise children as necessary until capable of using without supervision
- Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing)
- Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
- Children under 6 years of age: Do not use unless directed by a dentist or physician
Other Information
- Store at 59°-86°F (15°-30°C)
- Avoid excessive heat
Inactive Ingredients
Calcium Carbonate, Water, Sorbitol, Hydrated Silica, Sodium Lauryl Sulfate, Sodium Carboxymethyl Cellulose, Flavor, Sodium Saccharin, Sodium Methyl Paraben, Sodium Propyl Paraben
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