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

Description

Sodium Fluoride 0.02%

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Sodium Fluoride 0.02%

Uses

■ Help teeth whitening and reduce of bad breath

■ Aids in the prevention of gingivitis, periodontitis

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 [email protected]

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.

Package Label.principal Display Panel


Structured Label Content

Uses

■ Help teeth whitening and reduce of bad breath

■ Aids in the prevention of gingivitis, periodontitis

Purpose (PURPOSE)

Anticavity

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.

Questions (QUESTIONS)

■ www.tecozyme.com or [email protected]

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 (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 (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 (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


Raw Label Data

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