SPARKLEFRESH FLUORIDE- sodium monofluorophosphate paste, dentifrice

Sparklefresh Fluoride by

Drug Labeling and Warnings

Sparklefresh Fluoride by is a Otc medication manufactured, distributed, or labeled by IIMED MEDICAL MEXICANA S DE RL DE CV, Team Technologies. 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 if

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

Label

INGREDIENTS AND APPEARANCE

SPARKLEFRESH FLUORIDE 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83062-083(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
WATER (UNII: 059QF0KO0R)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SORBITOL (UNII: 506T60A25R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CALCIUM CARBONATE (UNII: H0G9379FGK)
SODIUM SILICATE (UNII: IJF18F77L3)
METHYLPARABEN (UNII: A2I8C7HI9T)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

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: 83062-083-93	24 g in 1 PACKET; Type 0: Not a Combination Product	10/06/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	10/06/2023

Labeler - IIMED MEDICAL MEXICANA S DE RL DE CV (812894376)

Registrant - Team Technologies (192339703)

Establishment
Name	Address	ID/FEI	Business Operations
IIMED MEDICAL MEXICANA S DE RL DE CV		812894376	relabel(83062-083) , repack(83062-083)