Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID f474e3ed-f5cf-43cb-a7ed-4ef8662e7b53

Route

DENTAL

Published

Effective Date 2013-07-13

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Fluoride Ion (20 mg)

Inactive Ingredients

Green Tea Leaf Xylitol Grapefruit Apple Peppermint Sodium Benzoate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2013-07-13

Description

sodium fluoride

Medication Information

Warnings and Precautions

keep away from heat and flame

Indications and Usage

- gargle a cap for about 60 seconds and then spit out

- in case of children under 6 years of age, use 1/2 cap and care for not swallowing

- before meeting, for old man or patient used easily

Dosage and Administration

for dental use only

Description

sodium fluoride

Section 50565-1

keep out of reach of the children

Section 51727-6

green tea extract, xylitol, grape fruit extract, apple fragrance, peppermint fragrance, sodium beozoate

Section 51945-4

Section 55105-1

dental care

Section 55106-9

sodium fluoride

Structured Label Content

Indications and Usage (34067-9)

- gargle a cap for about 60 seconds and then spit out

- in case of children under 6 years of age, use 1/2 cap and care for not swallowing

- before meeting, for old man or patient used easily

Dosage and Administration (34068-7)

for dental use only

Warnings and Precautions (34071-1)

keep away from heat and flame

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

green tea extract, xylitol, grape fruit extract, apple fragrance, peppermint fragrance, sodium beozoate

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

dental care

Section 55106-9 (55106-9)

sodium fluoride

Advanced Ingredient Data

[{"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "20", "strengthDenominator": "100000", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "GREEN TEA LEAF", "unii": "W2ZU1RY8B0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XYLITOL", "unii": "VCQ006KQ1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GRAPEFRUIT", "unii": "O82C39RR8C", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "APPLE", "unii": "B423VGH5S9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEPPERMINT", "unii": "V95R5KMY2B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "- gargle a cap for about 60 seconds and then spit out - in case of children under 6 years of age, use 1/2 cap and care for not swallowing - before meeting, for old man or patient used easily", "34068-7": "for dental use only", "34071-1": "keep away from heat and flame", "50565-1": "keep out of reach of the children", "51727-6": "green tea extract, xylitol, grape fruit extract, apple fragrance, peppermint fragrance, sodium beozoate", "55105-1": "dental care", "55106-9": "sodium fluoride"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:40.012915 · Updated: 2026-03-14T22:53:32.846368