Prevident 5000 Plus Spearmint

Prevident 5000 Plus Spearmint

Prevident 5000 Plus Spearmint Recall

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Questions & Answers

Side Effects & Adverse Reactions

Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water fluoridation exceeds 0.6 ppm, since younger pediatric patients frequently cannot perform the brushing process without significant swallowing. Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of dental cream which could cause dental fluorosis. Read directions carefully before using. Keep out of reach of infants and children.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

A dental caries preventive, for once daily self-applied topical use. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.1-4 PreviDent® 5000 Plus® brand of 1.1% sodium fluoride in a squeeze-tube is easily applied onto a toothbrush. This prescription dental cream should be used once daily in place of your regular toothpaste unless otherwise instructed by your dental professional. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (see WARNINGS for exception).

History

There is currently no drug history available for this drug.

Other Information

Self-topical neutral fluoride dentifrice containing 1.1% (w/w) sodium fluoride for use as a dental caries preventive in adults and pediatric patients.

Active Ingredient

Sodium fluoride 1.1% (w/w).

Inactive Ingredients

water, sorbitol, hydrated silica, PEG-12, tetrapotassium pyrophosphate, sodium lauryl sulfate, flavor (Spearmint flavor only), xanthan gum, flavor (Fruitastic™ flavor only), sodium benzoate, sodium saccharin, titanium dioxide (Fruitastic™ flavor only), FD&C blue no. 1 (Spearmint flavor only), D&C red no. 33 (Fruitastic™ flavor only).

Prevident 5000 Plus Spearmint Manufacturers


  • Colgate Oral Pharmaceuticals, Inc.
    Prevident 5000 Plus Spearmint (Sodium Fluoride) Paste, Dentifrice Prevident 5000 Plus Fruitastic (Sodium Fluoride) Paste, Dentifrice [Colgate Oral Pharmaceuticals, Inc.]
  • Colgate Oral Pharmaceuticals, Inc.
    Prevident 5000 Plus Spearmint (Sodium Fluoride) Paste, Dentifrice [Colgate Oral Pharmaceuticals, Inc.]

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