Treatment Rinse

Treatment Rinse
SPL v2
SPL
SPL Set ID f1255065-b7c3-4eb6-e053-2995a90afcdb
Route
DENTAL
Published
Effective Date 2022-05-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (226 ug)
Inactive Ingredients
Sodium Benzoate Water Xylitol Sodium Hydroxide Sodium Hypochlorite Menthol Polysorbate 20

Identifiers & Packaging

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

Description

Sodium Fluoride 0.05% when mixed with part B

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Sodium Fluoride 0.05% when mixed with part B

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:

Do not use before mixing with Part B. Adults and children 6 years of age and older: Use once daily after brushing. Shake each bottle before use. Using the measuring cup, combine 5 mL of component A with 5 mL of component B (10 mL, total). Vigorously swish the combined 10 mL 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. Do not dilute. Do not use either component alone. Store below 30 degrees C (86 degrees F). Do not freeze.

Active Ingredients:

Sodium Fluoride 0.05% when mixed with part B

Inactive Ingredients:

Menthol, Natural Flavors, Polysorbate 20, Sodium Benzoate, Sodium Hydroxide, Sodium Hypochlorite, Water, Xylitol.

Treatment Rinse Mint and Apple Enclosure and Carton 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:

Do not use before mixing with Part B. Adults and children 6 years of age and older: Use once daily after brushing. Shake each bottle before use. Using the measuring cup, combine 5 mL of component A with 5 mL of component B (10 mL, total). Vigorously swish the combined 10 mL 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. Do not dilute. Do not use either component alone. Store below 30 degrees C (86 degrees F). Do not freeze.

Active Ingredients: (Active ingredients:)

Sodium Fluoride 0.05% when mixed with part B

Inactive Ingredients: (Inactive ingredients:)

Menthol, Natural Flavors, Polysorbate 20, Sodium Benzoate, Sodium Hydroxide, Sodium Hypochlorite, Water, Xylitol.

Treatment Rinse Mint and Apple Enclosure and Carton Labels: (Treatment Rinse Mint and Apple enclosure and carton labels:)


Advanced Ingredient Data


Raw Label Data

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