Package Insert and Label Information: Iodent Fluoride Toothpaste

By Dabur India Limited | Last revised: 25 August 2008

IODENT FLUORIDE TOOTHPASTE- sodium monofluorophosphate 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.

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
IODENT^TM
CAVITY FIGHTING TOOTHPASTE
Fluoride
CAVITY PROTECTION & EXTRA RREATH FRESHENINGNET WT 6.4 OZ(181g)

CAVITY PROTECION

Regular Flavor

(click image for full-size original)

Fluoride Toothpaste Carton Label
FREE
Toothbrush
IODENT^TM
CAVITY FIGHTING TOOTHPASTE
Fluoride
CAVITY PROTECTION & EXTRA RREATH FRESHENINGNET WT 6.4 OZ(181g)

CAVITY PROTECION

Regular Flavor

(click image for full-size original)

IODENT FLUORIDE TOOTHPASTE fluoride toothpaste paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68747-6029
Route of Administration	DENTAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION)	SODIUM MONOFLUOROPHOSPHATE	7.6 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	MINT (MINT)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:68747-6029-1	181 g in 1 TUBE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	08/25/2009

Labeler — Dabur India Limited (650319218)

Establishment
Name	Address	ID/FEI	Operations
Dabur India Limited		650319218	MANUFACTURE

Revised: 08/2008 Dabur India Limited