Toothpaste

Toothpaste
SPL v5
SPL
SPL Set ID 8840080a-1068-4072-afcd-3e27f44f7bab
Route
ORAL
Published
Effective Date 2012-11-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1 mg)
Inactive Ingredients
Sorbitol Silicon Dioxide Calcium Carbonate Methylparaben Sodium Propylparaben Sodium Saccharin Sodium Water Carboxymethylcellulose Sodium Sodium Lauryl Sulfate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-06-08
Description

Sodium Monofluorophosphate 0.76 %

Indications and Usage

The prevention of dental cavities.

Purpose

Use Aids in the prevention of dental cavities.

Dosage and Administration

Directions: Adults and children 2 years and older Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician. Children under 6 years To minimize swallowing, use a pea sized amount and supervise brushing until good habits are established. Children under 2 years Ask a dentist or physician.

Medication Information

Indications and Usage
  • The prevention of dental cavities.
Purpose

Use Aids in the prevention of dental cavities.

Dosage and Administration

Directions:

  • Adults and children 2 years and older Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician.
  • Children under 6 years To minimize swallowing, use a pea sized amount and supervise brushing until good habits are established.
  • Children under 2 years Ask a dentist or physician.
Description

Sodium Monofluorophosphate 0.76 %

Warnings

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

Sodium Monofluorophosphate 0.76 %

Inactive Ingredient

Calcium carbonate, Carboxymethycellulose sodium, Flavour, Methylparaben sodium, Propylparaben sodium, Purified water, Saccharin sodium, Silicon dioxide, Sodium lauryl sulfate, Sorbitol

Purpose: Anticavity

Use

  • Aids in the prevention of dental cavities.
Principal Display Panel

Toothpaste.jpg

Keep Out of Reach of Children.

Keep out of reach of children under 6 years of age.

Structured Label Content

Warnings

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

Sodium Monofluorophosphate 0.76 %

Inactive Ingredient

Calcium carbonate, Carboxymethycellulose sodium, Flavour, Methylparaben sodium, Propylparaben sodium, Purified water, Saccharin sodium, Silicon dioxide, Sodium lauryl sulfate, Sorbitol

Purpose: Anticavity

Use

  • Aids in the prevention of dental cavities.
Indications and Usage
  • The prevention of dental cavities.
Principal Display Panel

Toothpaste.jpg

Dosage and Administration

Directions:

  • Adults and children 2 years and older Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician.
  • Children under 6 years To minimize swallowing, use a pea sized amount and supervise brushing until good habits are established.
  • Children under 2 years Ask a dentist or physician.
Keep Out of Reach of Children. (Keep out of reach of children.)

Keep out of reach of children under 6 years of age.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:37.184917 · Updated: 2026-03-14T22:53:28.900881