SPL v1
SPL
SPL Set ID e98b40d8-bf83-4a25-9514-bb4500099fc6
Route
ORAL
Published
Effective Date 2018-08-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.1 g)
Inactive Ingredients
Water Sorbitol Xylitol Carboxymethylcellulose Sodium Sodium Benzoate Xanthan Gum Saccharin Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-08-02
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 or contact a Poison Control Center immediately

Indications and Usage

Uses: Help protect teeth and roots 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
  • To minimize swallowing use a pea-sized amount in children under 6 years of age,
  • Supervise children's brushing untill good habits are established.

Children under 2 years of age:

  • Ask a dentist
Description

Active Ingredient Sodium Monofluorophosphate 0.76%

Section 50565-1

Keep out of reach of children

Section 51727-6

Inactive Ingredients:

Sorbitor, Water, Silica, Sodium N-Lauroylsarcosinate, Xylitol, Flavor, Sodium Carboxymethylcellulose, Sodium Benzoate, Xanthan Gum, Saccharin Sodium, Rose Red 1

Section 51945-4

Section 55105-1

Purpose:

Anticavity Toothpaste

Section 55106-9

Active Ingredient

Sodium Monofluorophosphate 0.76%

Structured Label Content

Indications and Usage (34067-9)

Uses: Help protect teeth and roots 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
  • To minimize swallowing use a pea-sized amount in children under 6 years of age,
  • Supervise children's brushing untill good habits are established.

Children under 2 years of age:

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

Warnings:

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

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

Inactive Ingredients:

Sorbitor, Water, Silica, Sodium N-Lauroylsarcosinate, Xylitol, Flavor, Sodium Carboxymethylcellulose, Sodium Benzoate, Xanthan Gum, Saccharin Sodium, Rose Red 1

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose:

Anticavity Toothpaste

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: 2026-02-15T11:56:36.931480 · Updated: 2026-03-14T22:55:12.436150