LEVEL ANTICAVITY TOOTHPASTE  - sodium monofluorophosphate paste 
Level Oral Care, LLC

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Level Mint Anticavity Toothpaste

Active Ingredient:                                                                                     Purpose

Sodium monofluorophoshate 0.76 percent                                                 Anticaries

Uses:

Aids in the prevention of dental cavities.

Warnings:

Keep out of reach children under 6 years of age.

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

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

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

cellulose gum, sodium benzoate, flavor

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

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Mint Five

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NET WT 5.0 oz (141.7 g)

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Mint One

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NET WT 1.0 oz (28.3 g)

LEVEL ANTICAVITY TOOTHPASTE  sodium monofluorophosphate   paste

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 50001-111 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) SODIUM MONOFLUOROPHOSPHATE 76 g  in 100 g

Inactive Ingredients Ingredient Name Strength WATER   GLYCERIN   SORBITOL   XYLITOL   SILICON DIOXIDE   CALCIUM CARBONATE   SODIUM PYROPHOSPHATE   SODIUM LAURYL SULFATE   SODIUM BICARBONATE   SACCHARIN   CROSCARMELLOSE SODIUM   SODIUM BENZOATE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 50001-111-50 141.7 g In 1 TUBE None 2 50001-111-10 28.3 g In 1 TUBE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part355	12/30/2009

Labeler - Level Oral Care, LLC (832019124)

Establishment
Name	Address	ID/FEI	Operations
American Lion Toothpaste Mfg. Sdn. Bhd		652244161	manufacture

Revised: 12/2009Level Oral Care, LLC