Premier Value Cavity Protection Mint
FDA Label NDC 68016-005

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Premier Value for the product Premier Value Cavity Protection Mint (NDC 68016-005). 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, otc - purpose, otc - keep out of reach of children, use, warnings, directions, principal display panel, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Sodium MonoFluoroPhosphate 0.76% (0.015% w/v fluoride ion)           ...Anticavity Toothpaste

Otc - Purpose


Otc - Keep Out Of Reach Of Children


Use

Helps protect against cavities.

Warnings

As with all fluoride toothpastes, keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.

Directions

Adults and children        Brush teeth thoroughly, preferably
2 years and older           after each meal, or at least twice a day, or as
                                    directed by your dentist. Do not swallow.

Children under                To minimize swallowing, use a pea-sized
6 years of age                amount and supervise brushing until
                                     good habits are established.

Children under 2 years     Ask a dentist or physician.

Inactive Ingredients

Sorbitol,Hydrated Silica,Water,Calcium Carbonate,Glycerine,Sodium Lauryl Sulphate,Cellulose Gum,Flavor,Sodium Benzoate,Sodium Saccharin, Sodium Phosphate,Titanium Dioxide,FDC BLUE NO. 1

* Please review the disclaimer below.