5820184 topco max str sens mint (80-15206 upd)

5820184 topco max str sens mint (80-15206 upd)
SPL v2
SPL
SPL Set ID 387d264c-90cc-5e67-e063-6394a90a713d
Route
dental
Published
Effective Date 2025-06-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (0.15 g) nitrate ion (5 g)
Inactive Ingredients
fd&c blue no. 1 water saccharin sodium sorbitol titanium dioxide glycerin xanthan gum hydrated silica sodium hydroxide cocamidopropyl betaine sucralose d&c yellow no. 10

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
otc monograph drug active Since 2025-06-26
Purpose

Potassium nitrate 5%....................................................Antihypersensitivity Sodium fluoride 0.24% (0.15% w/v fluoride ion)............Anticavity

Description

water, sorbitol, hydrated silica, glycerin, cocamidopropyl betaine, xanthan gum, flavor, titanium dioxide, sodium saccharin, sodium hydroxide, sucralose, yellow 10, blue 1

Medication Information

Warnings and Precautions

When using this product, if irritation occurs discontinue use.

Uses
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
  • aids in the prevention of dental cavities
Purpose

Potassium nitrate 5%....................................................Antihypersensitivity Sodium fluoride 0.24% (0.15% w/v fluoride ion)............Anticavity

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

Directions

Adults and children 12 years of age and older: apply at least a 1-inch strip of 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 tims a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimiza swallowing. Spit out after brushing.
  • children under 12 years of age: Consult a dentist or doctor.
Inactive Ingredients

water, sorbitol, hydrated silica, glycerin, cocamidopropyl betaine, xanthan gum, flavor, titanium dioxide, sodium saccharin, sodium hydroxide, sucralose, yellow 10, blue 1

Description

water, sorbitol, hydrated silica, glycerin, cocamidopropyl betaine, xanthan gum, flavor, titanium dioxide, sodium saccharin, sodium hydroxide, sucralose, yellow 10, blue 1

Section 50565-1

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

Section 50566-9

Stop use and ask a dentist if

  • the problem persists or worsen
  • Sensitive teeth may indicate a resious problem that may need prompt care by a dentist.
  • pain/sensitivity still persists after 4 weeks of use
Section 51945-4

Active Ingredients / Purpose

Potassium nitrate 5%....................................................Antihypersensitivity

Sodium fluoride 0.24% (0.15% w/v fluoride ion)............Anticavity

Structured Label Content

Warnings and Precautions (34071-1)

When using this product, if irritation occurs discontinue use.

Uses
  • 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. Children under 12 years of age:consult a dentist or a doctor.

Directions

Adults and children 12 years of age and older: apply at least a 1-inch strip of 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 tims a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimiza swallowing. Spit out after brushing.
  • children under 12 years of age: Consult a dentist or doctor.
Inactive Ingredients (Inactive ingredients)

water, sorbitol, hydrated silica, glycerin, cocamidopropyl betaine, xanthan gum, flavor, titanium dioxide, sodium saccharin, sodium hydroxide, sucralose, yellow 10, blue 1

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a dentist if

  • the problem persists or worsen
  • Sensitive teeth may indicate a resious problem that may need prompt care by a dentist.
  • pain/sensitivity still persists after 4 weeks of use
Section 51945-4 (51945-4)

Active Ingredients / Purpose (Active ingredients / Purpose)

Potassium nitrate 5%....................................................Antihypersensitivity

Sodium fluoride 0.24% (0.15% w/v fluoride ion)............Anticavity

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:42.722363 · Updated: 2026-03-14T23:09:37.690586