300303e7-ef8b-7449-e063-6294a90ac811

SPL v2
SPL
SPL Set ID 300303e7-ef8b-7449-e063-6294a90ac811
Route
dental
Published
Effective Date 2025-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (1.5 mg)
Inactive Ingredients
potassium phosphate poloxamer 407 carrageenan alpha-tocopherol acetate xanthan gum sucralose glycerin sodium hexametaphosphate thymol red 33 hydrated silica algin blue 1 lake cocamidopropyl betaine zinc stearate titanium dioxide water sodium saccharin eucalyptus globulus leaf peg-6 sodium lauryl sulfate potassium phosphate, tribasic

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-05-01
Purpose

Anticavity toothpaste

Description

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

Medication Information

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 directed 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, POTASSIUM PHOSPHATE, POLOXAMER 407, TITANIUM DIOXIDE, SODIUM SACCHARIN, ALGIN, BLUE 1 LAKE, TOCOPHERYL ACETATE, XANTHAN GUM, SUCRALOSE, RED 33, 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

Do Not

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.

Section 51945-4

Active Ingredient

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

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 directed 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, POTASSIUM PHOSPHATE, POLOXAMER 407, TITANIUM DIOXIDE, SODIUM SACCHARIN, ALGIN, BLUE 1 LAKE, TOCOPHERYL ACETATE, XANTHAN GUM, SUCRALOSE, RED 33, EUCALYPTUS GLOBULUS LEAF EXTRACT, THYMOL

Questions?

1-866-993-4709

Use

helps protect against cavities

Do Not (Do not)

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.

Section 51945-4 (51945-4)

Active Ingredient (Active ingredient)

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: 2026-02-15T12:06:02.263656 · Updated: 2026-03-14T23:08:29.204921