Drug Facts

Drug Facts

SPL v2

SPL

SPL Set ID be31c386-364e-43e6-a1d3-8ddaf8484e1c

Route

DENTAL

Published

Effective Date 2013-08-26

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Fluoride Ion (0.1 g) Allantoin (0.05 g)

Inactive Ingredients

Xylitol Methylparaben Water

Identifiers & Packaging

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2014-11-04

Description

sodium fluoride, allantoin

Medication Information

Warnings and Precautions

store at room temperature

Indications and Usage

spray out 1 time in mouth and gargle for 30 seconds

spray out 1 time in mouth and use toothbrush

Dosage and Administration

for dental use only

Description

sodium fluoride, allantoin

Section 50565-1

keep out of reach of the children

Section 51727-6

xylityl, glucosyl stevia, sodium lauroyl sarcosinate, hydroxyapatite, methylparaben, natural strawberry flavor, camellia sinensis leaf ext, water

Section 51945-4

Section 55105-1

for dental care

Section 55106-9

sodium fluoride, allantoin

Structured Label Content

Indications and Usage (34067-9)

spray out 1 time in mouth and gargle for 30 seconds

spray out 1 time in mouth and use toothbrush

Dosage and Administration (34068-7)

for dental use only

Warnings and Precautions (34071-1)

store at room temperature

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

xylityl, glucosyl stevia, sodium lauroyl sarcosinate, hydroxyapatite, methylparaben, natural strawberry flavor, camellia sinensis leaf ext, water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

for dental care

Section 55106-9 (55106-9)

sodium fluoride, allantoin

Advanced Ingredient Data

[{"name": "XYLITOL", "unii": "VCQ006KQ1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "0.1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ALLANTOIN", "unii": "344S277G0Z", "classCode": "ACTIB", "strengthNumerator": "0.05", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "spray out 1 time in mouth and gargle for 30 seconds spray out 1 time in mouth and use toothbrush", "34068-7": "for dental use only", "34071-1": "store at room temperature", "50565-1": "keep out of reach of the children", "51727-6": "xylityl, glucosyl stevia, sodium lauroyl sarcosinate, hydroxyapatite, methylparaben, natural strawberry flavor, camellia sinensis leaf ext, water", "55105-1": "for dental care", "55106-9": "sodium fluoride, allantoin"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:21.763582 · Updated: 2026-03-14T22:54:46.340416