FDA Label for Level Anticavity

View Indications, Usage & Precautions

Level Anticavity Product Label

The following document was submitted to the FDA by the labeler of this product Level Oral Care, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active Ingredient:                                                                                     Purpose

Sodium monofluorophoshate 0.76 percent                                                 Anticaries


Otc - Purpose



PurposeAnticaries

Indications & Usage



Uses:

Aids in the prevention of dental cavities.


Warnings



Warnings:


Do not swallow. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.


Otc - Keep Out Of Reach Of Children



Keep out of reach children under 6 years of age.


Dosage & Administration



Directions:

Adults and children 2 years of age and older: Apply Level Toothpaste onto a soft bristle toothbrush. Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

Children under 6 years of age: Instruct in good brushing and rinsing habits (to minimize swallowing). Use a pea-sized amount. Supervise children as necessary until capable of using without supervision.

Children under 2 years of age: Consult a dentist or doctor.


Inactive Ingredient



Inactive Ingredients: purified water, glycerin, sorbitol, xylitol hydrated silica, calcium carbonate,

tetrasodium pyrophosphate, sodium lauryl sulfate, sodium bicarbonate, sodium saccharin,

cellulose gum, sodium benzoate, flavor


Description



xylitol

Natural Enamel Protection

True Protection with fluoride

Gentle, yet powerful whitening agents

Ultimate freshness formula

Enamel Guard with pH stabilizers


Distributed by:
Level Oral Care, LLC
Jacksonville, FL 32246
www.leveloralcare.com
Product of MY

Package Label.Principal Display Panel



Level

Mint Five

Anticavity Toothpaste

perfect your smile



NET WT 5.0 oz (141.7 g)


Dosage Forms & Strengths



Level

Mint One

Anticavity Toothpaste

perfect your smile


NET WT 1.0 oz (28.3 g)


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