e1d973c2-ef96-4da5-abd2-6f4a30224850

SPL v1

SPL

SPL Set ID e1d973c2-ef96-4da5-abd2-6f4a30224850

Route

dental

Published

Effective Date 2021-08-17

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

fluoride ion (0.02 g)

Inactive Ingredients

water erythritol xylitol

Identifiers & Packaging

Marketing Status

otc monograph final active Since 2021-08-01

Purpose

Anticavity

Description

Sodium Fluoride 0.02%

Medication Information

Warnings

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.

Uses

■ Help teeth whitening and reduce of bad breath

■ Aids in the prevention of gingivitis, periodontitis

Purpose

Anticavity

Directions

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

Other Information

■ Read the directions and warnings before use

■ Store at room temperature

■ This rinse is not intended to replace brushing or flossing

Inactive Ingredients

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

Description

Sodium Fluoride 0.02%

Questions

■ www.tecozyme.com or [email protected]

Active Ingredient

Sodium Fluoride 0.02%

Keep Out of Reach of Children

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.

Package Label.principal Display Panel

Structured Label Content

Warnings (WARNINGS)

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.

Uses

■ Help teeth whitening and reduce of bad breath

■ Aids in the prevention of gingivitis, periodontitis

Purpose (PURPOSE)

Anticavity

Directions

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

Other Information

■ Read the directions and warnings before use

■ Store at room temperature

■ This rinse is not intended to replace brushing or flossing

Inactive Ingredients (INACTIVE INGREDIENTS)

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

Questions (QUESTIONS)

■ www.tecozyme.com or [email protected]

Active Ingredient (ACTIVE INGREDIENT)

Sodium Fluoride 0.02%

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

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.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Advanced Ingredient Data

[{"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "0.02", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "Water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Erythritol", "unii": "RA96B954X6", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Xylitol", "unii": "VCQ006KQ1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "■ Help teeth whitening and reduce of bad breath ■ Aids in the prevention of gingivitis, periodontitis", "PURPOSE": "Anticavity", "WARNINGS": "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.", "QUESTIONS": "■ www.tecozyme.com or contact@tecozyme.com", "Directions": "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", "ACTIVE INGREDIENT": "Sodium Fluoride 0.02%", "Other Information": "■ Read the directions and warnings before use ■ Store at room temperature ■ This rinse is not intended to replace brushing or flossing", "INACTIVE INGREDIENTS": "Water, Erythritol, Xylitol, Sodium Benzoate, Glycerin, Allantoin, Propylene Glycol, PEG-40 Hydrogenated Caster Oil, L-Menthol, Zinc Gluconate, Sodium Citrate, Fragrance", "KEEP OUT OF REACH OF CHILDREN": "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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:39.866382 · Updated: 2026-03-14T22:59:45.666904