Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID a7b8a58d-13fd-896e-e053-2995a90a5ec9

Route

TOPICAL

Published

Effective Date 2020-06-10

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Fluoride Ion (0.02 g)

Inactive Ingredients

Glycerin Allantoin Water Erythritol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2020-06-10

Description

sodium fluoride

Medication Information

Warnings and Precautions

For oral use only.

When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.

Stop use and ask a doctor if significant irritation or sensitization develops.

Indications and Usage

spit out the appropriate amount (120~15ml) for about 30 seconds after mouthing, and then brush the tooth bybrushing

Dosage and Administration

for oral use only

Description

sodium fluoride

Section 50565-1

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6

Water

Sodium Fluoride

Allantoin

Erythritol

xylitol

Sodium benzoate

Glycerin

Propylene Glycol

PEG-40 Hydrogenated Castor Oil

L-Menthol

zinc gluconate

sodium citrate

Fragrance

Section 51945-4

Section 55105-1

prevention of gingvitis, periodontitis, cavity, periodontal disease gum disease

Section 55106-9

sodium fluoride

Structured Label Content

Indications and Usage (34067-9)

spit out the appropriate amount (120~15ml) for about 30 seconds after mouthing, and then brush the tooth bybrushing

Dosage and Administration (34068-7)

for oral use only

Warnings and Precautions (34071-1)

For oral use only.

When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.

Stop use and ask a doctor if significant irritation or sensitization develops.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6 (51727-6)

Water

Sodium Fluoride

Allantoin

Erythritol

xylitol

Sodium benzoate

Glycerin

Propylene Glycol

PEG-40 Hydrogenated Castor Oil

L-Menthol

zinc gluconate

sodium citrate

Fragrance

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

prevention of gingvitis, periodontitis, cavity, periodontal disease gum disease

Section 55106-9 (55106-9)

sodium fluoride

Advanced Ingredient Data

[{"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALLANTOIN", "unii": "344S277G0Z", "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"}, {"name": "ERYTHRITOL", "unii": "RA96B954X6", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "spit out the appropriate amount (120~15ml) for about 30 seconds after mouthing, and then brush the tooth bybrushing", "34068-7": "for oral use only", "34071-1": "For oral use only. When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water. Stop use and ask a doctor if significant irritation or sensitization develops.", "50565-1": "KEEP OUT OF REACH OF THE CHILDREN", "51727-6": "Water Sodium Fluoride Allantoin Erythritol xylitol Sodium benzoate Glycerin Propylene Glycol PEG-40 Hydrogenated Castor Oil L-Menthol zinc gluconate sodium citrate Fragrance", "55105-1": "prevention of gingvitis, periodontitis, cavity, periodontal disease gum disease", "55106-9": "sodium fluoride"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:52.752487 · Updated: 2026-03-14T22:57:09.544683