IODENT FLUORIDE TOOTHPASTE- fluoride toothpaste paste, dentifrice

Iodent Fluoride Toothpaste by

Drug Labeling and Warnings

Iodent Fluoride Toothpaste by is a Otc medication manufactured, distributed, or labeled by Dabur India Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

IODENT FLUORIDE TOOTHPASTE 
fluoride toothpaste paste, dentifrice

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM MONOFLUOROPHOSPHATE	7.6 mg  in 1 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68747-6029-1	181 g in 1 TUBE

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	Business Operations
Dabur India Limited		650319218	MANUFACTURE