IDODENT FLOURIDE MINT- fluoride paste 
United Exchange Corp.

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.

----------

Active Ingredient                                                                                                 Purpose

Sodium monofluorophosphate 0.76%---------------------------------------------------- Anticavity

(Total Fluoride Content - 1000 ppm Approx.)

Uses

Regular brushing with fluoride toothpaste helps protect teeth and roots against cavities

Warnings

Warnings

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

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Directions

 Adults and children 2 years and older Brush Teeth thoroughly after meals, twice a day, or use as directed by a dentist or physician.
 Children under 6 years To minimize swallowing use a pea-sized amount and supervise brushing until good habits are established.
 Children under 2 years Ask a dentist or physician.

Other Information

Store at room temperature 20-25°C (68-77°F)

Inactive ingredients

calcium carbonate, water, sorbitol, hydrated silica, sodium lauryl sulfate, flavor, cellulose gum, sodium silicate, tetrasodium, propphosphate, sodium saccharin, titanium dioxide, methylparaben, PEG-8, propylparaben

Distributed by:

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703 USA

10101A

IDODENT FLOURIDE MINT 
fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-181
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.76 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
WATER (UNII: 059QF0KO0R)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM SILICATE (UNII: IJF18F77L3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65923-181-181 in 1 CARTON12/21/201610/13/2021
1181 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35510/23/2014
Labeler - United Exchange Corp. (840130579)

Revised: 11/2021
Document Id: d191f4ee-589e-c58b-e053-2995a90a5e2c
Set id: 35170ad8-53e5-4c69-82e3-7615da2f5087
Version: 5
Effective Time: 20211124
 
United Exchange Corp.