Skip to Content

LEVEL WINTERMINT FIVE WHITENING FORMULA ANTICAVITY

Medically reviewed on May 9, 2018

Dosage form: paste
Ingredients: SODIUM MONOFLUOROPHOSPHATE 0.76g in 100g
Labeler: LEVEL ORAL CARE, LLC
NDC Code: 50001-121

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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  
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50001-121
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) SODIUM MONOFLUOROPHOSPHATE0.76 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE 
WATER 
XYLITOL 
SORBITOL 
GLYCERIN 
SODIUM BICARBONATE 
CARBOXYMETHYLCELLULOSE SODIUM 
HYDRATED SILICA 
SODIUM LAURYL SULFATE 
SODIUM PYROPHOSPHATE 
SODIUM BENZOATE 
SACCHARIN SODIUM 
Packaging
#Item CodePackage Description
1NDC:50001-121-50141.7 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35608/16/2010
Labeler - LEVEL ORAL CARE, LLC (832019124)
Establishment
NameAddressID/FEIOperations
AmLion Toothpaste Mfg. Sdn. Bhd.652244161manufacture

 
LEVEL ORAL CARE, LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide