LEVEL ANTICAVITY - 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 Mint Anticavity Toothpaste

Active Ingredient:                                                                                     Purpose

Sodium monofluorophoshate 0.76 percent                                                 Anticaries

Purpose
Anticaries

Uses:

Aids in the prevention of dental cavities.

Warnings:


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 children under 6 years of age.

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
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LEVEL ANTICAVITY 
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50001-111
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE76 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
XYLITOL (UNII: VCQ006KQ1E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SACCHARIN (UNII: FST467XS7D)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50001-111-50141.7 g in 1 TUBE
2NDC:50001-111-1028.3 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35512/30/2009
Labeler - Level Oral Care, LLC (832019124)
Establishment
NameAddressID/FEIBusiness Operations
AmLion Toothpaste Mfg. Sdn. Bhd.652244161manufacture

Revised: 5/2011
Document Id: 347f2743-075b-46c7-82ad-19e4d5ba42b3
Set id: e968f453-0f8e-4ede-a42d-835b94d0ae56
Version: 9
Effective Time: 20110511
 
Level Oral Care, LLC