e7bf7e31-650d-4a1c-9100-48722344b201

SPL v6
SPL
SPL Set ID e7bf7e31-650d-4a1c-9100-48722344b201
Route
oral
Published
Effective Date 2022-08-01
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 2022-08-01

Purpose

Anticavity

Description

Sodium Fluoride 0.24%


Medication Information

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.

Uses

Aids in the prevention of dental cavities.

Purpose

Anticavity

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.

Inactive Ingredients

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

Description

Sodium Fluoride 0.24%

Product Label

● Questions?

●   Phone Support: 1-888-468-7404

Active Ingredient

Sodium Fluoride 0.24%


Structured Label Content

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.

Uses

Aids in the prevention of dental cavities.

Purpose

Anticavity

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.

Inactive Ingredients

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

Product Label (Product label)

● Questions?

●   Phone Support: 1-888-468-7404

Active Ingredient

Sodium Fluoride 0.24%


Advanced Ingredient Data


Raw Label Data

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