Universal Sensitive Anti-cavity Fluoride Toothpaste

Universal Sensitive Anti-cavity Fluoride Toothpaste
SPL v2
SPL
SPL Set ID fcf59439-7e06-4129-a89f-cdeecdf8d488
Route
DENTAL
Published
Effective Date 2020-05-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nitrate Ion (5 g) Fluoride Ion (0.15 g)
Inactive Ingredients
Sorbitol Water Silicon Dioxide Sodium Lauryl Sulfate Xanthan Gum Saccharin Sodium Sodium Benzoate Carboxymethylcellulose Sodium, Unspecified Titanium Dioxide Fd&c Blue No. 1 D&c Yellow No. 10

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-05-20
Description

Active Ingredients Potassium Nitrate  5% Sodium Fluoride- 0.32% (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 Ingredients Potassium Nitrate  5% Sodium Fluoride- 0.32% (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

Sorbitol, Water, Silica, Sodium lauryl sulfate, Xanthan gum, Sodium saccharin, Sodium benzoate, Sodium carboxy methyl cellulose, Titanium dioxide, Flavor, D&C yellow#10, FD&C blue#1

Section 51945-4

PRINCIPAL DISPLAY PANEL

UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE TOOTHPASTE

Section 55105-1

Purpose

Antihypersensitivity

Anticavity

Section 55106-9

Active Ingredients

Potassium Nitrate  5%

Sodium Fluoride- 0.32% (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

Sorbitol, Water, Silica, Sodium lauryl sulfate, Xanthan gum, Sodium saccharin, Sodium benzoate, Sodium carboxy methyl cellulose, Titanium dioxide, Flavor, D&C yellow#10, FD&C blue#1

Section 51945-4 (51945-4)

PRINCIPAL DISPLAY PANEL

UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE TOOTHPASTE

Section 55105-1 (55105-1)

Purpose

Antihypersensitivity

Anticavity

Section 55106-9 (55106-9)

Active Ingredients

Potassium Nitrate  5%

Sodium Fluoride- 0.32% (0.15% w/v fluoride ion)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:22.573125 · Updated: 2026-03-14T23:01:53.224533