LEVEL HERBAL MINT FIVE SENSITIVE FORMULA ANTICAVITY - potassium nitrate, sodium monofluorophosphate paste 
LEVEL ORAL CARE, LLC

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.

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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



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toothpastedrugpanel

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 AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM NITRATE5 g  in 100 g
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE0.76 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
XYLITOL (UNII: VCQ006KQ1E)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SORBITOL (UNII: 506T60A25R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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/FEIBusiness Operations
AmLion Toothpaste Mfg. Sdn. Bhd.652244161manufacture

Revised: 5/2011
Document Id: acbdcd4b-ada1-4f89-9046-428b73844128
Set id: b3012fa7-5200-4607-9bc6-43326ff38dde
Version: 4
Effective Time: 20110509
 
LEVEL ORAL CARE, LLC