SPARKLEFRESH FLUORIDE- sodium monofluorophosphate paste, dentifrice 
IIMED MEDICAL MEXICANA S DE RL DE CV

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IIMED SparkleFresh Fluoride Toothpaste

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

Entire Label

SPARKLEFRESH FLUORIDE 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83062-083(NDC:53329-083)
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83062-083-9324 g in 1 PACKET; Type 0: Not a Combination Product10/06/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02210/06/2023
Labeler - IIMED MEDICAL MEXICANA S DE RL DE CV (812894376)
Registrant - Team Technologies (192339703)
Establishment
NameAddressID/FEIBusiness Operations
IIMED MEDICAL MEXICANA S DE RL DE CV812894376relabel(83062-083) , repack(83062-083)

Revised: 10/2023
Document Id: 0715c095-f8b2-f6f8-e063-6294a90a2672
Set id: 0715c095-f8b1-f6f8-e063-6294a90a2672
Version: 1
Effective Time: 20231006
 
IIMED MEDICAL MEXICANA S DE RL DE CV