369c0d44-6375-dcae-e063-6394a90a74d0

SPL v4
SPL
SPL Set ID 369c0d44-6375-dcae-e063-6394a90a74d0
Route
dental
Published
Effective Date 2025-04-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (1.5 mg)
Inactive Ingredients
potassium phosphate, tribasic algin xanthan gum hydrated silica sodium saccharin zinc stearate sodium lauryl sulfate titanium dioxide thymol cocamidopropyl betaine poloxamer 407 .alpha.-tocopherol acetate glycerin sucralose red 33 yellow 6 eucalyptus globulus leaf sodium hexametaphosphate water peg-6 carrageenan potassium phosphate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-09-09
Purpose

Anticavity toothpaste

Description

Sodium Fluoride 0.243% (0.15% w/v fluoride ion)

Medication Information

Purpose

Anticavity toothpaste

Dosage and Administration

Do not swallow. If you accidentally swallow more than used for brushing, seek professional assistance or contact a poison control center right away. If an allergic reaction develops, discontinue use immediately.

Directions
  • adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directly by a dentist.
  • do not swallow.
  • to minimize swallowing use a pea-sized amount in children under 6.
  • supervise children's brushing until good habits are established.
  • children under 2 years: ask a dentist
Inactive Ingredients

Glycerin, Hydrated Silica, Sodium Hexametaphosphate, Water, Flavor/Aroma, PEG-6, Zinc Stearate, Cocamidopropyl Betaine, Sodium Lauryl Sulfate, Tripotassium Phosphate, Carrageenan, Titanium Dioxide, Potassium Phosphate, Poloxamer 407, Sodium Saccharin, Algin, Tocopheryl Acetate, Xanthan Gum, Sucralose, D&C Red 33(CI 17200), FD&C Yellow 6(CI 15985), Eucalyptus Globulus Leaf Extract, Thymol

Description

Sodium Fluoride 0.243% (0.15% w/v fluoride ion)

Questions?

1-866-993-4709

Use

helps protect against cavities

Section 51945-4

Active Ingredients

Sodium Fluoride 0.243%

(0.15% w/v fluoride ion)

Keep Out of Reach of Children

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

Structured Label Content

Purpose

Anticavity toothpaste

Dosage and Administration (34068-7)

Do not swallow. If you accidentally swallow more than used for brushing, seek professional assistance or contact a poison control center right away. If an allergic reaction develops, discontinue use immediately.

Directions
  • adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directly by a dentist.
  • do not swallow.
  • to minimize swallowing use a pea-sized amount in children under 6.
  • supervise children's brushing until good habits are established.
  • children under 2 years: ask a dentist
Inactive Ingredients (Inactive ingredients)

Glycerin, Hydrated Silica, Sodium Hexametaphosphate, Water, Flavor/Aroma, PEG-6, Zinc Stearate, Cocamidopropyl Betaine, Sodium Lauryl Sulfate, Tripotassium Phosphate, Carrageenan, Titanium Dioxide, Potassium Phosphate, Poloxamer 407, Sodium Saccharin, Algin, Tocopheryl Acetate, Xanthan Gum, Sucralose, D&C Red 33(CI 17200), FD&C Yellow 6(CI 15985), Eucalyptus Globulus Leaf Extract, Thymol

Questions?

1-866-993-4709

Use

helps protect against cavities

Section 51945-4 (51945-4)

Active Ingredients

Sodium Fluoride 0.243%

(0.15% w/v fluoride ion)

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: 2026-02-15T12:06:56.562356 · Updated: 2026-03-14T23:10:01.237919