Iodent Fluoride Toothpaste

Dosage form: paste, dentifrice
Ingredients: SODIUM MONOFLUOROPHOSPHATE 7.6mg in 1g
Labeler: Dabur India Limited
NDC Code: 68747-6029

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.

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

NET WT 6.4 OZ(181g)

CAVITY PROTECION

Regular Flavor

IODENT FLUORIDE TOOTHPASTE 
fluoride toothpaste paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68747-6029
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) SODIUM MONOFLUOROPHOSPHATE7.6 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE 
WATER 
SORBITOL 
SILICON DIOXIDE 
SODIUM LAURYL SULFATE 
CARBOXYMETHYLCELLULOSE SODIUM 
SODIUM SILICATE 
SODIUM PYROPHOSPHATE 
SACCHARIN SODIUM 
TITANIUM DIOXIDE 
METHYLPARABEN 
POLYETHYLENE GLYCOL 400 
PROPYLPARABEN 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (MINT) Imprint Code
Contains    
Packaging
#Item CodePackage Description
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/FEIOperations
Dabur India Limited650319218MANUFACTURE

Revised: 08/2008
 
Dabur India Limited

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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