5010570 natural white extreme sensitive whitening

5010570 natural white extreme sensitive whitening
SPL v6
SPL
SPL Set ID 9d7d08d7-8ca4-4b05-8b74-3bfa372b1608
Route
dental
Published
Effective Date 2025-06-17
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
water saccharin sodium sodium benzoate polyethylene glycol 600 sodium tripolyphosphate titanium dioxide glycerin fd&c red no. 40 hydrated silica cocamidopropyl betaine carboxymethylcellulose sodium

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
otc monograph drug completed Since 2012-12-01 Until 2023-05-23
Description

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

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
Dosage and Administration

Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Children under 12 years of age: ask a dentist.

Directions

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 recommneded 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.
Other Information

Store in a cool dry place. Keep tube capped when not in use.

Inactive Ingredients

Water, Hydrated Silica, Sorbitol, Glycerin, Cocamidopropyl Betaine, PEG-12, Titanium Dioxide, Cellulose Gum, Flavor, Sodium Benzoate, Sodium Saccharin, Red 40

Description

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

Section 50565-1

Keep out of reach of children. If more than used for brushing is accidentally 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 51945-4

Active Ingredient

Potassium nitrate 5% ................................................... Antisensitivity

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)

Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Children under 12 years of age: ask a dentist.

Directions

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 recommneded 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.
Other Information

Store in a cool dry place. Keep tube capped when not in use.

Inactive Ingredients (Inactive ingredients)

Water, Hydrated Silica, Sorbitol, Glycerin, Cocamidopropyl Betaine, PEG-12, Titanium Dioxide, Cellulose Gum, Flavor, Sodium Benzoate, Sodium Saccharin, Red 40

Section 50565-1 (50565-1)

Keep out of reach of children. If more than used for brushing is accidentally 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 51945-4 (51945-4)

Active Ingredient (Active ingredient)

Potassium nitrate 5% ................................................... Antisensitivity

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: 2026-02-15T12:06:43.303851 · Updated: 2026-03-14T23:09:39.646164