IODENT FLUORIDE MINT- sodium monofluorophosphate paste, dentifrice

Iodent Fluoride Mint by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

DOSAGE & ADMINISTRATION

• Directions Adults and children2 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

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

Principal Display Panel – Tube Label

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

INGREDIENTS AND APPEARANCE

IODENT FLUORIDE MINT 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68747-6032
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 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: 68747-6032-1	1 in 1 CARTON
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	02/28/2012

Labeler - Dabur India Limited (650319218)

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