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SPL v1

SPL

SPL Set ID ab2ac9bd-a090-31ad-e053-2a95a90aa25c

Route

DENTAL

Published

Effective Date 2020-07-24

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.02 g)

Inactive Ingredients

Xylitol Water Allantoin

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2020-07-24

Description

Sodium Fluoride, allantoin

Medication Information

Warnings and Precautions

Do not use in Children under 6 years of age

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

■ Vigorously swish 11 mL between teeth twice a day for 30 seconds then spit out.

■ Do not swallow

■ Children under 6 years of age: do not use

Dosage and Administration

For dental use only

Description

Sodium Fluoride, allantoin

Section 50565-1

Keep out of reach of children

Section 51727-6

Water, Erythritol, Xylitol, Sodium Benzoate, Glycerin, Propylene Glycol, PEG-40 Hydrogenated Caster Oil, L-Menthol, Zinc Gluconate, Sodium Citrate, Fragrance

Section 51945-4

Section 55105-1

■ Help teeth whitening and reduce of bad breath

■ Aids in the prevention of gingivitis, periodontitis

Section 55106-9

Sodium Fluoride, allantoin

Structured Label Content

Indications and Usage (34067-9)

Adults and children 6 years of age and older

■ Vigorously swish 11 mL between teeth twice a day for 30 seconds then spit out.

■ Do not swallow

■ Children under 6 years of age: do not use

Dosage and Administration (34068-7)

For dental use only

Warnings and Precautions (34071-1)

Do not use in Children under 6 years of age

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 children

Section 51727-6 (51727-6)

Water, Erythritol, Xylitol, Sodium Benzoate, Glycerin, Propylene Glycol, PEG-40 Hydrogenated Caster Oil, L-Menthol, Zinc Gluconate, Sodium Citrate, Fragrance

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

■ Help teeth whitening and reduce of bad breath

■ Aids in the prevention of gingivitis, periodontitis

Section 55106-9 (55106-9)

Sodium Fluoride, allantoin

Advanced Ingredient Data

[{"name": "XYLITOL", "unii": "VCQ006KQ1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "0.02", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ALLANTOIN", "unii": "344S277G0Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Adults and children 6 years of age and older ■ Vigorously swish 11 mL between teeth twice a day for 30 seconds then spit out. ■ Do not swallow ■ Children under 6 years of age: do not use", "34068-7": "For dental use only", "34071-1": "Do not use in Children under 6 years of age 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 children", "51727-6": "Water, Erythritol, Xylitol, Sodium Benzoate, Glycerin, Propylene Glycol, PEG-40 Hydrogenated Caster Oil, L-Menthol, Zinc Gluconate, Sodium Citrate, Fragrance", "55105-1": "■ Help teeth whitening and reduce of bad breath ■ Aids in the prevention of gingivitis, periodontitis", "55106-9": "Sodium Fluoride, allantoin"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:17.521531 · Updated: 2026-03-14T22:57:45.410763