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SparkleFresh

Medically reviewed on April 16, 2018

Dosage form: paste, dentifrice
Ingredients: SODIUM MONOFLUOROPHOSPHATE 0.1g in 100g
Labeler: Medline Industries, Inc.
NDC Code: 53329-081

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient

Sodium Monofluorophosphate 0.76%

Purpose

Anticavity Toothpaste

Use

Aids in the prevention of dental cavities

Warnings

Keep out of reach of children under 6 years of age.

If you accidentally swallow more than used for brushing, seek medical help or contact a Poison Center immediately.

Directions
  • Adults and children 2 yrs. and older: brush teeth thoroughly after meals or at least twice a day or as directed by a dentist or physician.
  • Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).
  • Supervise children as necessary until capable of using without supervision.
  • Children under 2 years of age: consult a dentist or physician.

Inactive ingredients

Calcium Carbonate, Carboxymethyl Cellulose, Flavor, Glycerin, Hydrated Silica, Sodium Benzoate, Sodium Lauryl Sulfate, Sodium Saccharin, Sorbitol, Tetrasodium Pyrophosphate, Water

Medline is a registered trademark and SparkleFresh is a trademark of Medline Industries Inc. Dignity Health and its logo are trademarks of Dignity Health. Manufactured for Medline Industries Inc., Mundelein, IL 60060 USA. Made in Malaysia To Order Call: 1-800-MEDLINE

Principal Display Panel

Dignity Health

SparkleFresh™

Fluoride Toothpaste

Net Wt. 0.85 oz (24g)

SPARKLEFRESH 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-081
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE 
SODIUM BENZOATE 
SODIUM LAURYL SULFATE 
SORBITOL 
SODIUM PYROPHOSPHATE 
WATER 
HYDRATED SILICA 
SACCHARIN SODIUM 
GLYCERIN 
CALCIUM CARBONATE 
Packaging
#Item CodePackage Description
1NDC:53329-081-9324 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35507/11/2013
Labeler - Medline Industries, Inc. (025460908)

 
Medline Industries, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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