Iodent Fluoride Toothpaste

Iodent Fluoride Toothpaste
SPL v2
SPL
SPL Set ID 78956871-f507-488c-915b-80bd0ddfd946
Route
DENTAL
Published
Effective Date 2008-08-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (7.6 mg)
Inactive Ingredients
Calcium Carbonate Water Sorbitol Silicon Dioxide Sodium Lauryl Sulfate Carboxymethylcellulose Sodium Sodium Silicate Sodium Pyrophosphate Saccharin Sodium Titanium Dioxide Methylparaben Polyethylene Glycol 400 Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2009-08-25

Description

Sodium Monofluorophosphate -0.76% (Total Fluoride Content -1000 ppm Approx.)

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Sodium Monofluorophosphate -0.76% (Total Fluoride Content -1000 ppm Approx.)

Use

Regular brushing with Fluoride toothpaste helps protect

teeth and roots against cavities

Section 51945-4

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

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)

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.

Active Ingredient

Sodium Monofluorophosphate -0.76%

(Total Fluoride Content -1000 ppm Approx.)

Children Under 2 Yrs

Ask a dentist or physician.

Children Under 6 Yrs

To minimize swallowing use a pea-sized amount and supervise brushing until good habits are established.

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.


Structured Label Content

Use (USE)

Regular brushing with Fluoride toothpaste helps protect

teeth and roots against cavities

Section 51945-4 (51945-4)

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

Purpose (PURPOSE)

Anticavity

Warning (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)

Ingredients (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.

Active Ingredient (ACTIVE INGREDIENT)

Sodium Monofluorophosphate -0.76%

(Total Fluoride Content -1000 ppm Approx.)

Children Under 2 Yrs (Children under 2 yrs)

Ask a dentist or physician.

Children Under 6 Yrs (Children under 6 yrs)

To minimize swallowing use a pea-sized amount and supervise brushing until good habits are established.

Adults and Children 2 Yrs, and Older (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.


Advanced Ingredient Data


Raw Label Data

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