Advanced Whitening Anti-cavity Fluoride Toothpaste

Advanced Whitening Anti-cavity Fluoride Toothpaste
SPL v1
SPL
SPL Set ID 591ac8f2-024a-4714-8a7b-eb8dc3bea528
Route
ORAL
Published
Effective Date 2017-06-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.5 mg)
Inactive Ingredients
Calcium Carbonate Fd&c Blue No. 1 Methylparaben Polyethylene Glycol 400 Propylparaben Carboxymethylcellulose Sodium, Unspecified Form Sodium Lauryl Sulfate Saccharin Sodium Sodium Silicate Sorbitol Sodium Pyrophosphate Titanium Dioxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-06-21
Description

Active Ingredient Sodium Fluoride (0.15% w/v fluoride ion)

Medication Information

Warnings and Precautions

Warning

Indications and Usage

Uses

  • builds increasing protection against painful sensitivity of teeth due to cold, heat, acids, sweets or contact.
  • aids in the prevention of dental cavities.
Dosage and Administration

Directions

Adults and Children 12 years of age and older:

  • apply at least a 1-inch strip of product onto soft bristle toothbrush
  • brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times day, or as recommended by a dentist or doctor.
  • make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after  brushing.

Children under 12 years of age: Consult a dentist or doctor.

Description

Active Ingredient Sodium Fluoride (0.15% w/v fluoride ion)

Section 42229-5

Other information

  • store in a cool, dry place.
Section 50565-1

Keep out of reach of children

  • If accidentally swallowed more than used for brushing, seek professional help or contact a Poison Control Center immediately.
Section 50566-9

Stop and ask a dentist

  • if the problem persists or worsens.

Sensitivity teeth may indicate a serious problem that may need prompt care by a dentist.

Section 50567-7

When using this product

  • if pain\ sensitivity still persists after 4 weeks of use, please visit your dentist.
Section 51727-6

Inactive Ingredients

calcium carbonate, FD&C blue#1, flavor, methylparaben, poly ethylene glycol 400, propylparaben, sodium carboxymethyl cellulose, sodium lauryl sulfate, sodium saccharin, sodium silicate, sorbitol, precipited silica, tetra sodium pyrophosphate, titanium dioxide, water.

Section 51945-4

PRINCIPAL DISPLAY PANEL

ADVANCED WHITENING ANTI-CAVITY FLUORIDE TOOTHPASTE

Section 55105-1

Purpose

Anticavity

Section 55106-9

Active Ingredient

Sodium Fluoride (0.15% w/v fluoride ion)

Structured Label Content

Indications and Usage (34067-9)

Uses

  • builds increasing protection against painful sensitivity of teeth due to cold, heat, acids, sweets or contact.
  • aids in the prevention of dental cavities.
Dosage and Administration (34068-7)

Directions

Adults and Children 12 years of age and older:

  • apply at least a 1-inch strip of product onto soft bristle toothbrush
  • brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times day, or as recommended by a dentist or doctor.
  • make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after  brushing.

Children under 12 years of age: Consult a dentist or doctor.

Warnings and Precautions (34071-1)

Warning

Section 42229-5 (42229-5)

Other information

  • store in a cool, dry place.
Section 50565-1 (50565-1)

Keep out of reach of children

  • If accidentally swallowed more than used for brushing, seek professional help or contact a Poison Control Center immediately.
Section 50566-9 (50566-9)

Stop and ask a dentist

  • if the problem persists or worsens.

Sensitivity teeth may indicate a serious problem that may need prompt care by a dentist.

Section 50567-7 (50567-7)

When using this product

  • if pain\ sensitivity still persists after 4 weeks of use, please visit your dentist.
Section 51727-6 (51727-6)

Inactive Ingredients

calcium carbonate, FD&C blue#1, flavor, methylparaben, poly ethylene glycol 400, propylparaben, sodium carboxymethyl cellulose, sodium lauryl sulfate, sodium saccharin, sodium silicate, sorbitol, precipited silica, tetra sodium pyrophosphate, titanium dioxide, water.

Section 51945-4 (51945-4)

PRINCIPAL DISPLAY PANEL

ADVANCED WHITENING ANTI-CAVITY FLUORIDE TOOTHPASTE

Section 55105-1 (55105-1)

Purpose

Anticavity

Section 55106-9 (55106-9)

Active Ingredient

Sodium Fluoride (0.15% w/v fluoride ion)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:22.263350 · Updated: 2026-03-14T22:54:46.340416