Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 71f907b8-8f28-4fd2-a035-b79cbf9ab860
Route
ORAL
Published
Effective Date 2016-01-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.06 mg)
Inactive Ingredients
Glycerin Allantoin Xylitol Stevioside Acetic Acid Sodium Bicarbonate Sodium Acetate Olea Europaea Leaf Sodium Benzoate Green Tea Leaf Saccharin Sodium Levomenthol Propolis Wax Lemon Oil Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-01-20
Description

Sodium Fluoride 0.02%

Medication Information

Warnings and Precautions

Stop use and ask a dentist if oral irritation or tooth sensitivity occurs

Indications and Usage

Aids in the prevention of dental cavities

Dosage and Administration

Adults and children 12 years of age and older:

• Use twice daily after brushing your teeth with a toothpaste

• Vigorously swish 10mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out

• Do not swallow the rinse

• Do not eat or drink for 30 minutes after rinsing

• Supervise children as necessary until capable of suing without supervisor

Children under 12 years of age: consult a dentist or doctor

Description

Sodium Fluoride 0.02%

Section 50565-1

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away

Section 51727-6

Glycerin, Allantoin, Xylitol, Stevioside, Acetic acid, Sodium bicarbonate, Sodium acetate, Olive leaf extract, Sodium Benzoate, Green Tea Extract, Sodium Saccharin, L-Menthol, Citrus flavoring, Lemon flavoring, Propolis Extract, Lemon Oil, Cacao Color, Purified water

Section 51945-4

Section 55105-1

Anticavity

Section 55106-9

Sodium Fluoride 0.02%

Structured Label Content

Indications and Usage (34067-9)

Aids in the prevention of dental cavities

Dosage and Administration (34068-7)

Adults and children 12 years of age and older:

• Use twice daily after brushing your teeth with a toothpaste

• Vigorously swish 10mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out

• Do not swallow the rinse

• Do not eat or drink for 30 minutes after rinsing

• Supervise children as necessary until capable of suing without supervisor

Children under 12 years of age: consult a dentist or doctor

Warnings and Precautions (34071-1)

Stop use and ask a dentist if oral irritation or tooth sensitivity occurs

Section 50565-1 (50565-1)

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away

Section 51727-6 (51727-6)

Glycerin, Allantoin, Xylitol, Stevioside, Acetic acid, Sodium bicarbonate, Sodium acetate, Olive leaf extract, Sodium Benzoate, Green Tea Extract, Sodium Saccharin, L-Menthol, Citrus flavoring, Lemon flavoring, Propolis Extract, Lemon Oil, Cacao Color, Purified water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Anticavity

Section 55106-9 (55106-9)

Sodium Fluoride 0.02%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:03.056229 · Updated: 2026-03-14T22:54:14.381059