Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID aa2e0864-3325-4acf-a2c5-0eb27eb18baf
Route
DENTAL
Published
Effective Date 2025-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (2.4 mg) Nitrate Ion (50 mg)
Inactive Ingredients
Sorbitol Silicon Dioxide Water Polyethylene Glycol 1600 Sodium Lauryl Sulfate Glycerin Carboxymethylcellulose Sodium, Unspecified Titanium Dioxide Sodium Phosphate, Tribasic, Dodecahydrate Saccharin Sodium Sodium Benzoate D&c Yellow No. 10 Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH DRUG Active Since 2010-09-16
Description

Potassium Nitrate - 5% Sodium Fluoride - 0.24%

Purpose

Potassium Nitrate - Antihypersensitivity Sodium Fluoride - Anticavity

Medication Information

Purpose

Potassium Nitrate - Antihypersensitivity

Sodium Fluoride - Anticavity

Description

Potassium Nitrate - 5% Sodium Fluoride - 0.24%

Uses

Builds increasing protection against painful sensitivity of teeth due to cold, heat, acids, sweets or contact.

Aids in the prevention of dental cavities

Section 51945-4

Warnings

Stop and ask a dentist if

  • The problem persists or worsens.  Sensitive teeth may indicate a serious problem that may require prompt care by a dentist
  • Pain / sensitivity still persists after 4 weeks of use
Directions

Adults and children 12 years and older:  

  • Apply at least a 1-inch strip of the product onto a soft bristle toothbrush.
  • Brush teet thoroughly for at least 1 minute twice a day (morning and evening), or as recommended by your dentist.  Make sure to brush all sensitive areas of the teeth.  Minimize swallowing.  Spit out after brushing

Children under 12 years of age:consult a doctor.

Active Ingredients

Potassium Nitrate - 5%

Sodium Fluoride - 0.24%

Inactive Ingredients

Sorbitol, Silica, Treated Water, PEG-32, Sodium Lauryl Sulfate, Glycerin, Flavor, Cellulose Gum, Titanium Dioxide, Trisodium Phosphate, Sodium Saccharin, Sodium Benzoate,  Color: D and C Yellow # 10, FD and C Blue # 1.

Keep Out of Reach of Children

If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.

Structured Label Content

Uses

Builds increasing protection against painful sensitivity of teeth due to cold, heat, acids, sweets or contact.

Aids in the prevention of dental cavities

Section 51945-4 (51945-4)

Purpose

Potassium Nitrate - Antihypersensitivity

Sodium Fluoride - Anticavity

Warnings

Stop and ask a dentist if

  • The problem persists or worsens.  Sensitive teeth may indicate a serious problem that may require prompt care by a dentist
  • Pain / sensitivity still persists after 4 weeks of use
Directions

Adults and children 12 years and older:  

  • Apply at least a 1-inch strip of the product onto a soft bristle toothbrush.
  • Brush teet thoroughly for at least 1 minute twice a day (morning and evening), or as recommended by your dentist.  Make sure to brush all sensitive areas of the teeth.  Minimize swallowing.  Spit out after brushing

Children under 12 years of age:consult a doctor.

Active Ingredients

Potassium Nitrate - 5%

Sodium Fluoride - 0.24%

Inactive Ingredients

Sorbitol, Silica, Treated Water, PEG-32, Sodium Lauryl Sulfate, Glycerin, Flavor, Cellulose Gum, Titanium Dioxide, Trisodium Phosphate, Sodium Saccharin, Sodium Benzoate,  Color: D and C Yellow # 10, FD and C Blue # 1.

Keep Out of Reach of Children (Keep out of reach of Children)

If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:25.035155 · Updated: 2026-03-14T23:10:48.259693