Maintenance Rinse

Maintenance Rinse
SPL v2
SPL
SPL Set ID f1273510-aa83-3ef9-e053-2a95a90aea27
Route
DENTAL
Published
Effective Date 2013-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (226 ug)
Inactive Ingredients
Polysorbate 20 Potassium Sorbate Sodium Benzoate Sodium Bicarbonate Water Xylitol Menthol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-05-10

Description

Sodium Fluoride 0.05%

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Sodium Fluoride 0.05%

Use:

Aids in the prevention of dental caries (cavities)

Purpose:

Anticavity

Warnings:

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away. If you experience any unusual symptoms, stop use and contact your dentist.

Directions:

Adults and children 6 years of age and older: Use once daily after brushing your teeth with toothpaste. Vigorously swish 10mL of rinse between teeth for one minute, then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing. Instruct children under 12 years of age in good rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: Consult a dentist or physician. Store below 30 degrees C (86 degrees F). Do not freeze.

Active Ingredients:

Sodium Fluoride 0.05%

Inactive Ingredients:

Menthol (Mint only), Natural Flavors (Mint only), Natural and Artificial Flavors (Citrus and Grape only), Polysorbate 20, Potassium Sorbate, Sodium Benzoate, Sodium Bicarbonate, Water, Xylitol

Maintenance Mint, Citrus, and Grape Enclosure Labels:


Structured Label Content

Use:

Aids in the prevention of dental caries (cavities)

Purpose:

Anticavity

Warnings:

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away. If you experience any unusual symptoms, stop use and contact your dentist.

Directions:

Adults and children 6 years of age and older: Use once daily after brushing your teeth with toothpaste. Vigorously swish 10mL of rinse between teeth for one minute, then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing. Instruct children under 12 years of age in good rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: Consult a dentist or physician. Store below 30 degrees C (86 degrees F). Do not freeze.

Active Ingredients: (Active ingredients:)

Sodium Fluoride 0.05%

Inactive Ingredients: (Inactive ingredients:)

Menthol (Mint only), Natural Flavors (Mint only), Natural and Artificial Flavors (Citrus and Grape only), Polysorbate 20, Potassium Sorbate, Sodium Benzoate, Sodium Bicarbonate, Water, Xylitol

Maintenance Mint, Citrus, and Grape Enclosure Labels: (Maintenance Mint, Citrus, and Grape enclosure labels:)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)