b7174b69-6158-42de-b122-1752cd184ca9 — v1

4 Views

Version

v1

Effective date

August 25, 2008

Original packager

Sections captured

10

Identifiers

Document ID
75c4b06a-1942-49b5-bcf9-27c936e14051
Set ID
b7174b69-6158-42de-b122-1752cd184ca9
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 Fluoride - 0.243% (0.15% w/v fluoride ion)
Dosage And Administration (1)

Sequence 1

DIRECTIONS: Adults and children 2 years & older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist. Do not swallow. To minimize swallowing use a pea-sized amount in children under 6 years of age. Supervise children's brushing until good habits are established. Children under 2 years: Ask a dentist.
Inactive Ingredient (1)

Sequence 1

INACTIVE INGREDIENTS: Sorbitol, Silica, Treated Water (Aqua), Glycerin, Polyethylene Glycol 1500, Sodium Lauryl Sulphate, Flavor, Titanium Dioxide, Cellulose Gum, Carrageenan, Trisodium Orthophosphate, Sodium Saccharin, Sodium Benzoate, Tetrasodium Pyrophosphate, Methylparaben, Propylparaben, Color: FD & C Blue # 1.
Indications And Usage (1)

Sequence 1

USES: Helps protect teeth and roots against cavities.
Keep Out Of Reach Of Children (1)

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Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.
Package Label Principal Display Panel (1)

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Principal Display Panel – Tube Label ADA Accepted American Dental Association ® freshmint ® Premium Anticavity Toothpaste NET WT. 1.5 oz Principal Display Panel – Tube Label
Purpose (1)

Sequence 1

PURPOSE: Anticavity
Spl Product Data Elements (1)

Sequence 1

Freshmint Premium Anticavity SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION SORBITOL SILICON DIOXIDE WATER GLYCERIN POLYETHYLENE GLYCOL 1500 SODIUM LAURYL SULFATE TITANIUM DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM CARRAGEENAN SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE SACCHARIN SODIUM DIHYDRATE SODIUM BENZOATE SODIUM PYROPHOSPHATE METHYLPARABEN PROPYLPARABEN FD&C BLUE NO. 1 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. If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.