SPARKLEFRESH FLOURIDE TOOTHPASTE- 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, treated water, sorbitol, precipitated silica, sodium lauryl sulfate, flavor, sodium carboxymethyl cellulose, sodium silicate, tetrasodium pyrophosphate, sodium saccharin, methylparaben, titanium dioxide, polyethylene glycol 400, propylparaben

Questions

• 1-800-MEDLINE

Principal Display Panel

INGREDIENTS AND APPEARANCE

SPARKLEFRESH  FLOURIDE TOOTHPASTE
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-083
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM SILICATE (UNII: IJF18F77L3)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
CALCIUM CARBONATE (UNII: H0G9379FGK)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SORBITOL (UNII: 506T60A25R)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
WATER (UNII: 059QF0KO0R)
METHYLPARABEN (UNII: A2I8C7HI9T)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-083-21	42.5 g in 1 TUBE; Type 0: Not a Combination Product	08/01/2019
2	NDC: 53329-083-92	17 g in 1 PACKET; Type 0: Not a Combination Product	08/01/2019
3	NDC: 53329-083-93	24 g in 1 PACKET; Type 0: Not a Combination Product	08/01/2019
4	NDC: 53329-083-94	78 g in 1 TUBE; Type 0: Not a Combination Product	08/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/01/2007

Labeler - Medline Industries, Inc. (025460908)

Establishment
Name	Address	ID/FEI	Business Operations
Dabur India Limited		650599231	manufacture(53329-083)