Iodent Fluoride Toothpaste
FDA Label NDC 68747-6029

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dabur India Limited for the product Iodent Fluoride Toothpaste (NDC 68747-6029). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, use, warning, adults and children 2 yrs, and older, children under 6 yrs, children under 2 yrs, ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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)

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.

Package Label.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

Fluoride Toothpaste Tube Label (Fluoride Tooth 01)

Fluoride Toothpaste Tube Label (Fluoride Tooth 01)

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

Fluoride Toothpaste Carton Label (Fluoride Tooth 02)

Fluoride Toothpaste Carton Label (Fluoride Tooth 02)

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