LEVEL WINTERMINT FIVE WHITENING FORMULA ANTICAVITY TOOTHPASTE  - sodium monofluorophosphate paste 
LEVEL ORAL CARE, LLC

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LEVEL WINTERMINT FIVE WHITENING FORMULA ANTICAVITY TOOTHPASTE perfect your smile

DRUG FACTS

Active Ingredient                                                    Purpose

Sodium Monofluorophosphate 0.76%....Anticaries

Purpose
Anticaries

Uses:

Aids in the prevention of dental cavities.

WARNING

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

Keep out of reach of children under 6 years of age.

DIRECTIONS

Adults and children 2 years of age and older:

Apply Level Toothpaste on to a soft bristle toothbrush. Brush 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

Calcium Carbonate, Purified Water, Xylitol, Sorbitol, Glycerin, Sodium Bicarbonate, Cellulose Gum, Hydrated Silica, Sodium Lauryl Sulfate, Flavor, Tetrasodium Pyrophosphate, Sodium Benzoate, Sodium Saccharin

Xylitol

Natural Enamel protection

True protection with fluoride

Ultra concentrated whitening agents

Active stain removal

Invigorating winter mint

enamel guard with pH stabilizers


Distributed by

Level Oral Care, LLC

Jacksonville, FL 32246

www.leveloralcare.com

Product of MY

Level

Wintermint Five

Whitening Formula

Anticavity Toothpaste

perfect your smile


NET WT. 5.0 OZ (141.7G)


Xylitol

natural enamel protection

True protection with fluoride

Ultra concentrated whitening agents
Active stain removal

Invigorating winter mint

Enamel Guard with pH stabilizers


ACTIVE INGREDIENT:

Sodium monofluorophosphate 0.76%


USES:

Aids in the prevention of dental cavities


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. Instruct children under 6 years of age 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

WARNINGS

Keep out of reach of children under 6 years of age. Do not swallow. if more than used from brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.


Distributed by:

Level Oral Care, LLC
Jacksonville, FL 32246
www.leveloralcare.com

LEVEL WINTERMINT FIVE WHITENING FORMULA ANTICAVITY TOOTHPASTE  sodium monofluorophosphate   paste

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 50001-121 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) SODIUM MONOFLUOROPHOSPHATE 0.76 g  in 100 g

Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE   WATER   XYLITOL   SORBITOL   GLYCERIN   SODIUM BICARBONATE   CARBOXYMETHYLCELLULOSE SODIUM   HYDRATED SILICA   SODIUM LAURYL SULFATE   SODIUM PYROPHOSPHATE   SODIUM BENZOATE   SACCHARIN SODIUM

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 50001-121-50 141.7 g In 1 TUBE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part356	08/16/2010

Labeler - LEVEL ORAL CARE, LLC (832019124)

Establishment
Name	Address	ID/FEI	Operations
AMERICAN LION TOOTHPASTE MFG. SDN. BHD		652244161	manufacture

Revised: 08/2010LEVEL ORAL CARE, LLC