FDA Label for Iodent Fluoride Mint

View Indications, Usage & Precautions

Iodent Fluoride Mint Product Label

The following document was submitted to the FDA by the labeler of this product Dabur India Limited. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



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


Otc - Keep Out Of Reach Of Children



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 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.


Package Label.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 – Tube Label

IODENT® CAVITY FIGHTING TOOTHPASTE
FLUORIDE Mint Flavor
CAVITY PROTECTION & EXTRA BREATH FRESHENING

NET WT 6.4 OZ (181g)


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