5820090 Topcare Enamel Guard Intensive (8015074)

5820090 Topcare Enamel Guard Intensive (8015074)
SPL v4
SPL
SPL Set ID 3012a8da-7595-2f7c-e063-6294a90ae120
Route
ORAL
Published
Effective Date 2025-06-17
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
Cocamidopropyl Betaine Sorbitol Glycerin Peg-8 Xanthan Gum Titanium Dioxide Water Sodium Saccharin Hydrated Silica Sodium Hydroxide

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2025-06-17 Until 2025-09-30
Description

Potassium nitrate 5% Sodium fluoride 0.25% (0.15% w/v fluoride ion)

Medication Information

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

adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristle toothbrush

  • brush teeth thoroughly for at least one minute twice a day (morning and evening), and not more than 3 times a 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

Potassium nitrate 5% Sodium fluoride 0.25% (0.15% w/v fluoride ion)

Section 50565-1

Keep out of reach of children. If more than used for brushing is acidentally swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a dentist if

  • the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
  • pain/sensitivity still persists after 4 weeks of use.
Section 50567-7

When using this product, if irritation occurs discontinue use.

Section 51727-6

water, hydrated silica, sorbitol, glycerin, PEG-8, flavor, cocamidopropyl betaine, titanium dioxide, xanthan gum, sodium saccharin, sodium hydroxide

Section 51945-4

Section 55105-1

Antihypersensitivity

Anticavity

Section 55106-9

Potassium nitrate 5%

Sodium fluoride 0.25% (0.15% w/v fluoride ion)

Structured Label Content

Indications and Usage (34067-9)
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
  • aids in the prevention of dental cavities
Dosage and Administration (34068-7)

adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristle toothbrush

  • brush teeth thoroughly for at least one minute twice a day (morning and evening), and not more than 3 times a 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.
Section 50565-1 (50565-1)

Keep out of reach of children. If more than used for brushing is acidentally swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a dentist if

  • the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
  • pain/sensitivity still persists after 4 weeks of use.
Section 50567-7 (50567-7)

When using this product, if irritation occurs discontinue use.

Section 51727-6 (51727-6)

water, hydrated silica, sorbitol, glycerin, PEG-8, flavor, cocamidopropyl betaine, titanium dioxide, xanthan gum, sodium saccharin, sodium hydroxide

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antihypersensitivity

Anticavity

Section 55106-9 (55106-9)

Potassium nitrate 5%

Sodium fluoride 0.25% (0.15% w/v fluoride ion)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:07:07.724447 · Updated: 2026-03-14T23:10:21.394156