5820097 Heb Sensitive Extra Whitening Twinpack (8015201)

5820097 Heb Sensitive Extra Whitening Twinpack (8015201)
SPL v2
SPL
SPL Set ID 41d5ae3e-51c1-263b-e063-6394a90a3312
Route
ORAL
Published
Effective Date 2025-12-01
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 Peg-8 Glycerin Hydrated Silica Sodium Saccharin Titanium Dioxide Sodium Methyl Cocoyl Taurate Xanthan Gum Sorbitol Sodium Hydroxide Pentasodium Triphosphate Cocamidopropyl Betaine

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-01
Description

Potassium nitrate 5% ...................................................... Anthihypersensitivity 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.

Indications and Usage

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.
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% ...................................................... Anthihypersensitivity 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 50567-7

When using this product, if irritation occurs discontinue use.

Section 51727-6

water, sorbitol, hydrated silica, glycerin, pentasodium triphosphate, PEG-8, flavor, titanium dioxide, sodium methyl cocoyl taurate, cocamidopropyl betaine, xanthan gum, sodium hydroxide, sodium saccharin

Section 51945-4

Section 53413-1

Questions or comments? 1-877-777-2743

Section 55105-1

Antihypersensitivity

Anticavity

Section 55106-9

Potassium nitrate 5% ...................................................... Anthihypersensitivity

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

Structured Label Content

Indications and Usage (34067-9)

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.
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.
Warnings and Precautions (34071-1)

When using this product, if irritation occurs discontinue use.

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 50567-7 (50567-7)

When using this product, if irritation occurs discontinue use.

Section 51727-6 (51727-6)

water, sorbitol, hydrated silica, glycerin, pentasodium triphosphate, PEG-8, flavor, titanium dioxide, sodium methyl cocoyl taurate, cocamidopropyl betaine, xanthan gum, sodium hydroxide, sodium saccharin

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? 1-877-777-2743

Section 55105-1 (55105-1)

Antihypersensitivity

Anticavity

Section 55106-9 (55106-9)

Potassium nitrate 5% ...................................................... Anthihypersensitivity

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: 2026-02-15T12:07:41.640982 · Updated: 2026-03-14T23:11:26.161918