SPL v1
SPL
SPL Set ID 8002ddc8-9a7b-407d-8c20-51e5736fd65a
Route
ORAL
Published
Effective Date 2018-01-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.1 g)
Inactive Ingredients
Sodium Phosphate Fd&c Blue No. 1 Water Sorbitol Sodium Lauryl Sulfate Carboxymethylcellulose Sodium Glycerin Xanthan Gum Menthol Saccharin Sodium Xylitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-01-16
Description

Active Ingredient Sodium Monofluorophosphate 0.76%

Medication Information

Warnings and Precautions

Warnings:

If you accidentally swallow more than used for brushing, seek professional help 

Indications and Usage

Uses:

Helps protect  against 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.
  • Do not swallow
  • Children under 6 Years of Age
  • To minimize swallowing use a pea-sized amount and supervise children's brushing untill good habits are established.

Children under 2 years of age:

  • Ask a dentist or physician
Description

Active Ingredient Sodium Monofluorophosphate 0.76%

Section 50565-1

Keep out of reach of children under 6 years of age

Section 51727-6

Inactive Ingredients:

Sorbitor, Water, Silica, Glycerin, Sodium Lauryl Suphate, Flavor, PEG-1500, Sodium Carboxymethylcellulose, Xylitol, Xanthan Gum, Sodium Methyl Paraben, Sodium Phosphate, Sodium Propyl Paraben, Sodium Saccharin, Cooling Crystal, FD&C Blue 1

Section 51945-4

Section 55105-1

Purpose:

Anticavity

Section 55106-9

Active Ingredient

Sodium Monofluorophosphate 0.76%

Structured Label Content

Indications and Usage (34067-9)

Uses:

Helps protect  against cavities

Dosage and Administration (34068-7)

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.
  • Do not swallow
  • Children under 6 Years of Age
  • To minimize swallowing use a pea-sized amount and supervise children's brushing untill good habits are established.

Children under 2 years of age:

  • Ask a dentist or physician
Warnings and Precautions (34071-1)

Warnings:

If you accidentally swallow more than used for brushing, seek professional help 

Section 50565-1 (50565-1)

Keep out of reach of children under 6 years of age

Section 51727-6 (51727-6)

Inactive Ingredients:

Sorbitor, Water, Silica, Glycerin, Sodium Lauryl Suphate, Flavor, PEG-1500, Sodium Carboxymethylcellulose, Xylitol, Xanthan Gum, Sodium Methyl Paraben, Sodium Phosphate, Sodium Propyl Paraben, Sodium Saccharin, Cooling Crystal, FD&C Blue 1

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose:

Anticavity

Section 55106-9 (55106-9)

Active Ingredient

Sodium Monofluorophosphate 0.76%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:29.836146 · Updated: 2026-03-14T22:55:00.598631