Made By Dentists Enamel Rebuilding Professional

Made By Dentists Enamel Rebuilding Professional
SPL v2
SPL
SPL Set ID 178d7538-c178-b8ca-e063-6394a90a7d33
Route
DENTAL
Published
Effective Date 2024-02-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nitrate Ion (50 mg) Fluoride Ion (1.5 mg)
Inactive Ingredients
Carboxymethylcellulose Sodium, Unspecified Cocamidopropyl Betaine Hydrated Silica Tribasic Calcium Phosphate Sodium Tripolyphosphate Anhydrous Potassium Sorbate Sodium Bicarbonate Saccharin Sodium Sorbitol Titanium Dioxide Water Xylitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-01
Description

Potassium Nitrate 5.0% Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Purpose

Antisensitivity Anticavity 

Medication Information

Purpose

Antisensitivity

Anticavity 

Description

Potassium Nitrate 5.0% Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Use:

Aids in the prevention of cavities. Helps reduce painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.

Label

Warnings:

Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or doctor.

Drug Facts

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 1 minute twice a day, (morning and evening) or as recommended by a dentist or doctor.
  • Make sure to brush all sensitive areas of the teeth.
  • Children under 12 years of age: Consult a dentist or doctor.
Active Ingredient:

Potassium Nitrate 5.0%

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

Inactive Ingredients:

Cellulose Gum, Cocamidopropyl Betaine, Flavor, Hydrated Silica, Hydroxyapatite, Pentasodium Triphosphate, Potassium Sorbate, Sodium Bicarbonate, Sodium Saccharin, Sorbitol, Titanium Dioxide, Water (Aqua), Xylitol

Questions Or Comments?

+ 1 (646) 980-6461

Keep Out of Reach of Children Under 6 Years of Age.

If more than used for brushing is accidentlly swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Use:

Aids in the prevention of cavities. Helps reduce painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.

Label

Purpose

Antisensitivity

Anticavity 

Warnings:

Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or doctor.

Drug Facts

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 1 minute twice a day, (morning and evening) or as recommended by a dentist or doctor.
  • Make sure to brush all sensitive areas of the teeth.
  • Children under 12 years of age: Consult a dentist or doctor.
Active Ingredient: (Active ingredient:)

Potassium Nitrate 5.0%

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

Inactive Ingredients: (Inactive ingredients:)

Cellulose Gum, Cocamidopropyl Betaine, Flavor, Hydrated Silica, Hydroxyapatite, Pentasodium Triphosphate, Potassium Sorbate, Sodium Bicarbonate, Sodium Saccharin, Sorbitol, Titanium Dioxide, Water (Aqua), Xylitol

Questions Or Comments? (Questions or comments?)

+ 1 (646) 980-6461

Keep Out of Reach of Children Under 6 Years of Age. (Keep out of reach of children under 6 years of age.)

If more than used for brushing is accidentlly swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:21.910549 · Updated: 2026-03-14T23:09:06.809873