Label: LEVEL ANTICAVITY- sodium monofluorophosphate paste

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated May 11, 2011

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  • ACTIVE INGREDIENT

    Active Ingredient:                                                                                     Purpose

    Sodium monofluorophoshate 0.76 percent                                                 Anticaries

  • PURPOSE

    Purpose
    Anticaries
  • INDICATIONS & USAGE

    Uses:

    Aids in the prevention of dental cavities.

  • WARNINGS

    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 OF CHILDREN

    Keep out of reach children under 6 years of age.

  • DOSAGE & ADMINISTRATION

    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 INGREDIENT

    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

  • DESCRIPTION

    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
    Product of MY
  • PRINCIPAL DISPLAY PANEL

    Level

    Mint Five

    Anticavity Toothpaste

    perfect your smile



    NET WT 5.0 oz (141.7 g)

  • PRINCIPAL DISPLAY PANEL

    MintToothpaste
  • PRINCIPAL DISPLAY PANEL

    MintToothpasteDrugFacts

  • DOSAGE FORMS & STRENGTHS

    Level

    Mint One

    Anticavity Toothpaste

    perfect your smile


    NET WT 1.0 oz (28.3 g)

  • PRINCIPAL DISPLAY PANEL

    MintToothpaste1oz

  • INGREDIENTS AND APPEARANCE
    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
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