78956871-f507-488c-915b-80bd0ddfd946 — v2

4 Views

Version

v2

Effective date

August 25, 2008

Original packager

Sections captured

6

Identifiers

Document ID
3161f610-bf6e-45ee-89b4-10f65c908c61
Set ID
78956871-f507-488c-915b-80bd0ddfd946
Application numbers
Product NDCs
Package NDCs
Original packager NDCs

Names & Manufacturers

Brand names
Generic names
Manufacturer names
Product types

Substances & Pharmacology

Substance names
Routes
Pharmacologic class (PE)
Pharmacologic class (EPC)
Pharmacologic class (CS)
Mechanism of action

Other identifiers

NUI
RxCUI
UNII
UPC

Structured Label Sections

Active Ingredient (1)

Sequence 1

ACTIVE INGREDIENT Sodium Monofluorophosphate -0.76% (Total Fluoride Content -1000 ppm Approx.)
Package Label Principal Display Panel (2)

Sequence 1

Fluoride Toothpaste Tube Label FREE Toothbrush IODENT TM CAVITY FIGHTING TOOTHPASTE Fluoride CAVITY PROTECTION & EXTRA RREATH FRESHENING NET WT 6.4 OZ(181g) CAVITY PROTECION Regular Flavor Fluoride Toothpaste Tube Label

Sequence 2

Fluoride Toothpaste Carton Label FREE Toothbrush IODENT TM CAVITY FIGHTING TOOTHPASTE Fluoride CAVITY PROTECTION & EXTRA RREATH FRESHENING NET WT 6.4 OZ(181g) CAVITY PROTECION Regular Flavor Fluoride Toothpaste Carton Label
Purpose (1)

Sequence 1

PURPOSE Anticavity
Spl Product Data Elements (1)

Sequence 1

Iodent Fluoride Toothpaste Fluoride Toothpaste SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION CALCIUM CARBONATE WATER SORBITOL SILICON DIOXIDE SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE SODIUM SODIUM SILICATE SODIUM PYROPHOSPHATE SACCHARIN SODIUM TITANIUM DIOXIDE METHYLPARABEN POLYETHYLENE GLYCOL 400 PROPYLPARABEN MINT
Spl Unclassified Section (4)

Sequence 1

Drug Facts

Sequence 2

USE Regular brushing with Fluoride toothpaste helps protect teeth and roots against cavities

Sequence 3

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.

Sequence 4

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.
Warnings (1)

Sequence 1

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)