7bbd3de6-b26b-49bf-80e8-717d6b33ed17 — v1

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Version

v1

Effective date

August 25, 2008

Original packager

Sections captured

10

Identifiers

Document ID
7bbd3de6-b26b-49bf-80e8-717d6b33ed17
Set ID
7bbd3de6-b26b-49bf-80e8-717d6b33ed17
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 Potassium Nitrate - 5 % Sodium Fluoride - 0.24 %
Dosage And Administration (1)

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DIRECTIONS
Inactive Ingredient (1)

Sequence 1

INACTIVE INGREDIENTS: Sorbitol, Silica, Treated Water, Poly Ethylene Glycol 1500, Sodium Lauryl Sulphate, Glycerin, Flavor, Sodium Carboxy Methyl Cellulose, Titanium Dioxide, Tri Sodium Ortho Phosphate, Sodium Saccharin, Sodium Benzoate, Methyl Paraben, Propyl Paraben, Color D & C Yellow # 10, FD & C Blue # 1.
Indications And Usage (1)

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USES builds increasing protection against painful sensitivity of teeth due to cold, heat, acids, sweets or contact aids in the prevention of dental cavities
Package Label Principal Display Panel (1)

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Principal Display Panel - NET WT. 4.3 OZ (122g) Freshmint Sensitive Toothpaste Tube Label freshmint ® Sensitive Toothpaste NET WT. 4.3 OZ (122g) Anti-cavity Fluoride Tootpaste for Sensitive *Compare to the Active Ingredients of Sensodyne ® Fresh Mint Freshmint Sensitive Toothpaste Carton Label freshmint ® Sensitive Toothpaste NET WT. 4.3 OZ (122g) Anti-cavity Fluoride Tootpaste for Sensitive *Compare to the Active Ingredients of Sensodyne ® Fresh Mint Principal Display Panel- Tube Label - NET WT. 4.3 OZ (122g) Principal Display Panel - Carton Label - NET WT. 4.3 OZ (122g)
Purpose (1)

Sequence 1

PURPOSE Antihypersensitivity Anticavity
Spl Product Data Elements (1)

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Freshmint Sensitive Toothpaste Fluoride Toothpaste SODIUM FLUORIDE FLUORIDE ION POTASSIUM NITRATE POTASSIUM CATION SORBITOL SILICON DIOXIDE WATER POLYETHYLENE GLYCOL 1500 SODIUM LAURYL SULFATE GLYCERIN CARBOXYMETHYLCELLULOSE SODIUM TITANIUM DIOXIDE SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE SACCHARIN SODIUM SODIUM BENZOATE METHYLPARABEN PROPYLPARABEN white MINT
Spl Unclassified Section (1)

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Drug Facts: ACTIVE INGREDIENT Potassium Nitrate - 5 % Sodium Fluoride - 0.24 % PURPOSE Antihypersensitivity Anticavity USES builds increasing protection against painful sensitivity of teeth due to cold, heat, acids, sweets or contact aids in the prevention of dental cavities WARNINGS When using this product do not use longer than 4 weeks unless recommended by a dentist or doctor. Stop and ask a dentist if problem persists or worsens. Sensitive teeth may indicate a serious problem that may require prompt care by a dentist. Keep out of reach of children. If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately. DIRECTIONS Adults and children 12 years and older Brush teeth for at least one minute, preferably after each meal, or at least twice a day, or as directed by your dentist. Be sure to brush sensitive areas Children under 12 years of age Consult a dentist or doctor. Other information Store In a cool dry place. INACTIVE INGREDIENTS: Sorbitol, Silica, Treated Water, Poly Ethylene Glycol 1500, Sodium Lauryl Sulphate, Glycerin, Flavor, Sodium Carboxy Methyl Cellulose, Titanium Dioxide, Tri Sodium Ortho Phosphate, Sodium Saccharin, Sodium Benzoate, Methyl Paraben, Propyl Paraben, Color D & C Yellow # 10, FD & C Blue # 1.
Warnings (1)

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WARNINGS
When Using (1)

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When using this product do not use longer than 4 weeks unless recommended by a dentist or doctor. Stop and ask a dentist if problem persists or worsens. Sensitive teeth may indicate a serious problem that may require prompt care by a dentist. Keep out of reach of children. If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.