Drug Facts

Drug Facts

SPL v2

SPL

SPL Set ID 06e9dc12-acc5-3d79-e063-6294a90ad7a6

Route

DENTAL

Published

Effective Date 2023-10-05

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Fluoride Ion (0.02 g)

Inactive Ingredients

Xylitol Glycerin Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-10-05

Description

sodium fluoride

Medication Information

Warnings and Precautions

if more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away

Indications and Usage

Adults and children 6 years of age and older:

use twoce a day after brishing your teeth with a toothpaste

vigorously swish contents of one (1) 11mL packet 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

instruct children under 12 years of age in good rinsing habits (to minimize swallowing)

supervise children as necessary until capable of using without supervision

Children uder 6 years of age: consult a dentist or doctor

Dosage and Administration

for dental use only

Description

sodium fluoride

Section 50565-1

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6

purified water, glycerin, xylitol, green tea extract, acetic acid, strawberry flavoring, sodium acetate, grapefruit seed extract, sodium benzoate, L-menthol, sodium saccharin, chitosan

Section 51945-4

Section 55105-1

aids in the prevention of dental cavities

Section 55106-9

sodium fluoride

Structured Label Content

Indications and Usage (34067-9)

Adults and children 6 years of age and older:

use twoce a day after brishing your teeth with a toothpaste

vigorously swish contents of one (1) 11mL packet 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

instruct children under 12 years of age in good rinsing habits (to minimize swallowing)

supervise children as necessary until capable of using without supervision

Children uder 6 years of age: consult a dentist or doctor

Dosage and Administration (34068-7)

for dental use only

Warnings and Precautions (34071-1)

if more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6 (51727-6)

purified water, glycerin, xylitol, green tea extract, acetic acid, strawberry flavoring, sodium acetate, grapefruit seed extract, sodium benzoate, L-menthol, sodium saccharin, chitosan

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

aids in the prevention of dental cavities

Section 55106-9 (55106-9)

sodium fluoride

Advanced Ingredient Data

[{"name": "XYLITOL", "unii": "VCQ006KQ1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIB", "strengthNumerator": "0.02", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Adults and children 6 years of age and older: use twoce a day after brishing your teeth with a toothpaste vigorously swish contents of one (1) 11mL packet 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 instruct children under 12 years of age in good rinsing habits (to minimize swallowing) supervise children as necessary until capable of using without supervision Children uder 6 years of age: consult a dentist or doctor", "34068-7": "for dental use only", "34071-1": "if more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away", "50565-1": "KEEP OUT OF REACH OF THE CHILDREN", "51727-6": "purified water, glycerin, xylitol, green tea extract, acetic acid, strawberry flavoring, sodium acetate, grapefruit seed extract, sodium benzoate, L-menthol, sodium saccharin, chitosan", "55105-1": "aids in the prevention of dental cavities", "55106-9": "sodium fluoride"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:01:20.782895 · Updated: 2026-03-14T23:01:21.342577