SPL v3
SPL
SPL Set ID 35839b10-4c40-40e5-e063-6294a90a85b4
Route
DENTAL
Published
Effective Date 2025-06-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.5 mg)
Inactive Ingredients
Algin Xanthan Gum Glycerin Red 33 Yellow 6 Potassium Phosphate Titanium Dioxide Thymol Poloxamer 407 Zinc Stearate Cocamidopropyl Betaine Carrageenan Sucralose Potassium Phosphate, Tribasic Sodium Hexametaphosphate Peg-6 Hydrated Silica Sodium Saccharin .alpha.-tocopherol Acetate Eucalyptus Globulus Leaf Water Sodium Lauryl Sulfate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-09
Description

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

Purpose

Anticavity toothpaste

Medication Information

Warnings and Precautions

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.

Description

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

Use

helps protect against cavities

Section 51945-4

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
Questions?

1-866-993-4709

Active Ingredients

Sodium Fluoride 0.243%

(0.15% w/v fluoride ion)

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

Keep Out of Reach of Children

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

Structured Label Content

Use

helps protect against cavities

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.

Warnings and Precautions (34071-1)

Section 51945-4 (51945-4)

Purpose

Anticavity toothpaste

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
Questions?

1-866-993-4709

Active Ingredients

Sodium Fluoride 0.243%

(0.15% w/v fluoride ion)

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

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: 2026-02-15T12:06:15.554072 · Updated: 2026-03-14T23:08:56.104871