Prevident 5000 Enhanced With Calcium Mint

Prevident 5000 Enhanced With Calcium Mint

Prevident 5000 Enhanced With Calcium Mint 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 toothpaste which could cause dental fluorosis. Pediatric patients under age 12 should be supervised in the use of this product. 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 BoosterPlus brand of 1.1% sodium fluoride toothpaste in a squeeze bottle is easily applied onto a toothbrush. This prescription toothpaste 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, poloxamer 338, flavor (Spearmint only), sodium lauryl sulfate, xanthan gum, flavor (Fruitastic™ only), sodium benzoate, sodium saccharin, mica, tricalcium phosphate, fumaric acid, titanium dioxide, FD&C blue no. 1 (Spearmint only), D&C Red no. 33 (Fruitastic™ only)

Prevident 5000 Enhanced With Calcium Mint Manufacturers


  • Colgate Oral Pharmaceuticals, Inc.
    Prevident 5000 Enhanced With Calcium Mint (Sodium Fluoride) Paste, Dentifrice [Colgate Oral Pharmaceuticals, Inc.]
  • Colgate Oral Pharmaceuticals, Inc.
    Prevident 5000 Enhanced With Calcium Mint (Sodium Fluoride) Paste, Dentifrice [Colgate Oral Pharmaceuticals, Inc.]

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