LEVEL ANTICAVITY (SODIUM MONOFLUOROPHOSPHATE) PASTE [LEVEL ORAL CARE, LLC ]

LEVEL ANTICAVITY (SODIUM MONOFLUOROPHOSPHATE) PASTE [LEVEL ORAL CARE, LLC ]
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NDC 50001-111-10, 50001-111-50
Set ID e968f453-0f8e-4ede-a42d-835b94d0ae56
Category HUMAN OTC DRUG LABEL
Packager Level Oral Care, LLC
Generic Name
Product Class
Product Number
Application Number PART355
  • 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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