SPL v6
SPL
SPL Set ID 37a4e712-e3b5-42f6-971c-98dea4b8dd06
Route
ORAL
Published
Effective Date 2022-11-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.24 g)
Inactive Ingredients
Water Glycerin Sorbitol Poloxamer 407 Xylitol Silver Potassium Sorbate Stevioside Citric Acid Monohydrate Calcium Citrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-12-01

Description

Sodium Fluoride 0.24%

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Sodium Fluoride 0.24%

Uses

Aids in the prevention of dental cavities.

Warnings

Keep out of reach of children under 6 years of age. If more than used for brushing

is accidentally swallowed, get medical help or contact a Poison Control Central right away.

Directions

Adults and children 2 years of age and older: Brush teeth thoroughly, preferably

after each meal or at least twice per day, or as directed by a dentist or physician.

● Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).

● Shake before use.

● Squirt two times into your mouth and start brushing.

● Supervise children as necessary until capable of using without supervision.

Children under 2 years of age: consult a dentist or physician.

Product Label

● Questions?

●   Phone Support: 1-888-468-7404

Active Ingredient

Sodium Fluoride 0.24%

Inactive Ingredients

Aqua, Glycerin, Sorbitol, Poloxamer, Xylitol, Natural Watermelon Flavor, Nano Silver, Potassium Sorbate, Stevioside, Citric Acid, Calcium Citrate


Structured Label Content

Uses

Aids in the prevention of dental cavities.

Purpose

Anticavity

Warnings

Keep out of reach of children under 6 years of age. If more than used for brushing

is accidentally swallowed, get medical help or contact a Poison Control Central right away.

Directions

Adults and children 2 years of age and older: Brush teeth thoroughly, preferably

after each meal or at least twice per day, or as directed by a dentist or physician.

● Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).

● Shake before use.

● Squirt two times into your mouth and start brushing.

● Supervise children as necessary until capable of using without supervision.

Children under 2 years of age: consult a dentist or physician.

Product Label (Product label)

● Questions?

●   Phone Support: 1-888-468-7404

Active Ingredient

Sodium Fluoride 0.24%

Inactive Ingredients

Aqua, Glycerin, Sorbitol, Poloxamer, Xylitol, Natural Watermelon Flavor, Nano Silver, Potassium Sorbate, Stevioside, Citric Acid, Calcium Citrate


Advanced Ingredient Data


Raw Label Data

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