1d8494e9-56b6-4c0d-af3e-a156044c577a — v1

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Version

v1

Effective date

August 25, 2008

Original packager

Sections captured

11

Identifiers

Document ID
0b12c46c-f046-4cb1-a290-4795b196e2ff
Set ID
1d8494e9-56b6-4c0d-af3e-a156044c577a
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 Monofluorophospate 0.76% (Total Fluoride Content – 1000 ppm Approx.)
Dosage And Administration (1)

Sequence 1

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.
Dosage And Administration Table (1)

Sequence 1

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.
Inactive Ingredient (1)

Sequence 1

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.
Indications And Usage (1)

Sequence 1

Uses Regular brushing with Fluoride toothpaste helps protect teeth and roots against cavities
Keep Out Of Reach Of Children (1)

Sequence 1

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.
Package Label Principal Display Panel (2)

Sequence 1

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 – Carton Label

Sequence 2

Principal Display Panel – Tube Label IODENT ® CAVITY FIGHTING TOOTHPASTE FLUORIDE Mint Flavor CAVITY PROTECTION & EXTRA BREATH FRESHENING NET WT 6.4 OZ (181g) Principal Display Panel – Tube Label
Purpose (1)

Sequence 1

Purpose Anticavity
Spl Product Data Elements (1)

Sequence 1

Iodent Fluoride Mint SODIUM MONOFLUOROPHOSPHATE SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION CALCIUM CARBONATE WATER SORBITOL SILICON DIOXIDE SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE SODIUM SODIUM PYROPHOSPHATE SACCHARIN SODIUM TITANIUM DIOXIDE METHYLPARABEN POLYETHYLENE GLYCOL 400 PROPYLPARABEN MINT
Spl Unclassified Section (1)

Sequence 1

Drug Facts
Warnings (1)

Sequence 1

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.