SPARKLEFRESH- sodium monofluorophosphate paste, dentifrice

SparkleFresh by

Drug Labeling and Warnings

SparkleFresh by is a Otc medication manufactured, distributed, or labeled by Medline Industries, LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

SPARKLEFRESH 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-081
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SORBITOL (UNII: 506T60A25R)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
GLYCERIN (UNII: PDC6A3C0OX)
CALCIUM CARBONATE (UNII: H0G9379FGK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-081-93	24 g in 1 TUBE; Type 0: Not a Combination Product	07/11/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	07/11/2013

Labeler - Medline Industries, Inc. (025460908)