LEVEL HERBAL MINT FIVE SENSITIVE FORMULA ANTICAVITY

Dosage form: paste
Ingredients: POTASSIUM NITRATE 5g in 100g, SODIUM MONOFLUOROPHOSPHATE 0.76g in 100g
Labeler: LEVEL ORAL CARE, LLC
NDC Code: 50001-131

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 HERBAL MINT FIVE SENSITIVE FORMULA ANTICAVITY TOOTHPASTE perfect your smile

DRUG FACTS

Active Ingredient                                        Purpose

Potassium Nitrate 5%                               Antihypersensitivity

Sodium Monofluorophosphate 0.76%....Anticaries


Purpose:
Antihypersensitivity and Anticaries

Uses:

Builds increasing protection against painful sensitivity of the teeth due to cold, heat acids, sweets, or contact

Aids in the prevention of dental cavities.

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

Dicalcium Phosphate Dihydrate, Purified WAter, Xylitol, Glycerin, Hydrated Silica, Sorbitol, Carboxy Methyl Cellulose, Sodium Lauryl sulfate, Flavor, Tetrasodium Pyrophosphate, Sodium Bicarbonate, Sodium Benzoate, Sodium Saccharin

Xylitol

Natural Enamel protection

True protection with fluoride

Advanced pain-blocking technology

Soothing herbal mint

enamel guard with pH stabilizers



Distributed by

level oral care, LLC

Jacksonville, FL 32246

www.leveloralcare.com

Product of MY

Level

Herbal Mint Five

Sensitive Formula

Anticavity Toothpaste

perfect your smile



NET WT. 5.0 OZ (141.7G)



Xylitol

natural enamel protection

True protection with fluoride

Advanced pain-blocking technology

Soothing herbal mint

Enamel Guard with pH stabilizers



ACTIVE INGREDIENT:

Potassium nitrate 5%

Sodium monofluorophosphate 0.76%



USES:

Builds increasing protection against painful sensitivity of the teeth due to cold heat acids, sweets or contact. 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 HERBAL MINT FIVE SENSITIVE FORMULA ANTICAVITY 
potassium nitrate, sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50001-131
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM NITRATE (POTASSIUM CATION) POTASSIUM NITRATE5 g  in 100 g
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) SODIUM MONOFLUOROPHOSPHATE0.76 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
XYLITOL 
GLYCERIN 
HYDRATED SILICA 
SORBITOL 
SODIUM LAURYL SULFATE 
SODIUM PYROPHOSPHATE 
SODIUM BICARBONATE 
SODIUM BENZOATE 
SACCHARIN SODIUM 
Packaging
#Item CodePackage Description
1NDC:50001-131-50141.7 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35608/12/2010
Labeler - LEVEL ORAL CARE, LLC (832019124)
Establishment
NameAddressID/FEIOperations
AmLion Toothpaste Mfg. Sdn. Bhd.652244161manufacture

Revised: 05/2011
 
LEVEL ORAL CARE, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web4)