Your browser does not support JavaScript! IODENT FLUORIDE MINT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [DABUR INDIA LIMITED]
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IODENT FLUORIDE MINT (sodium monofluorophosphate) paste, dentifrice
[Dabur India Limited]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Drug Facts

Active Ingredient

Sodium Monofluorophospate 0.76%

(Total Fluoride Content – 1000 ppm Approx.)

Purpose

Anticavity

Uses

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

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 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.

Principal Display Panel – Carton Label

IODENT® CAVITY FIGHTING TOOTHPASTE
FLUORIDE Mint Flavor
CAVITY PROTECTION & EXTRA BREATH FRESHENING
NET WT 6.4 OZ (181g)

Principal Display Panel – Carton Label

Principal Display Panel – Tube Label

IODENT® CAVITY FIGHTING TOOTHPASTE
FLUORIDE Mint Flavor
CAVITY PROTECTION & EXTRA BREATH FRESHENING
NET WT 6.4 OZ (181g)

Principal Display Panel – Tube Label
IODENT FLUORIDE MINT 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68747-6032
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 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:68747-6032-11 in 1 CARTON
1181 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/28/2012
Labeler - Dabur India Limited (650319218)
Establishment
NameAddressID/FEIBusiness Operations
Dabur India Limited650319218MANUFACTURE

Revised: 08/2008
Document Id: 0b12c46c-f046-4cb1-a290-4795b196e2ff
Set id: 1d8494e9-56b6-4c0d-af3e-a156044c577a
Version: 1
Effective Time: 20080825
 
Dabur India Limited

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