IODENT FLUORIDE TOOTHPASTE- fluoride toothpaste paste, dentifrice 
Dabur India Limited

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.

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Iodent Fluoride Toothpaste

Drug Facts

ACTIVE INGREDIENT

Sodium Monofluorophosphate -0.76%

(Total Fluoride Content -1000 ppm Approx.)

PURPOSE

Anticavity

USE

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

WARNING

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

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

Drug Facts (continued)

DIRECTIONS

Adults and children 2 yrs, and older

Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician.

Children under 6 yrs

To minimize swallowing use a pea-sized amount and supervise brushing until good habits are established.

Children under 2 yrs

Ask a dentist or physician.

INGREDIENTS

Calcium Carbonate, Water, Sorbitol, Precipitated Silica, Sodium Lauryl Sulphate, Flavor, Sodium
Carboxy, Methyl Cellulose, Sodium Silicate, Tetra Sodium Pyrophosphate, Sodium Saccharin, Methyl
Paraben, Titanium Dioxide, Poly Ethylene Glycol 400, Propyl Paraben, Color: F D & C Blue # 1.

Fluoride Toothpaste Tube Label
FREE
Toothbrush
IODENTTM
CAVITY FIGHTING TOOTHPASTE         
Fluoride
CAVITY PROTECTION & EXTRA RREATH FRESHENING

NET WT 6.4 OZ(181g)

CAVITY PROTECION

Regular Flavor

Fluoride Toothpaste Tube Label

Fluoride Toothpaste Carton Label
FREE
Toothbrush
IODENTTM
CAVITY FIGHTING TOOTHPASTE         
Fluoride
CAVITY PROTECTION & EXTRA RREATH FRESHENING

NET WT 6.4 OZ(181g)

CAVITY PROTECION

Regular Flavor

Fluoride Toothpaste Carton Label
IODENT FLUORIDE TOOTHPASTE 
fluoride toothpaste paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68747-6029
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE7.6 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SODIUM SILICATE (UNII: IJF18F77L3)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (MINT) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68747-6029-1181 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35508/25/2009
Labeler - Dabur India Limited (650319218)
Establishment
NameAddressID/FEIBusiness Operations
Dabur India Limited650319218MANUFACTURE

Revised: 8/2008
Document Id: 3161f610-bf6e-45ee-89b4-10f65c908c61
Set id: 78956871-f507-488c-915b-80bd0ddfd946
Version: 2
Effective Time: 20080825
 
Dabur India Limited