Label: ADVANCED WHITENING ANTICAVITY FLUORIDE- sodium monofluorophosphate paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 December 30, 2011

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  • ACTIVE INGREDIENT

    Active Ingredent

    Sodium Monofluorophosphate 0.76%

  • PURPOSE

    Purpose

    Anticavity toothpaste

  • INDICATIONS & USAGE

    Use

    Aids in the prevention of cavities

  • WARNINGS

    If more than is 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 of children under 6 yrs of age.

  • DOSAGE & ADMINISTRATION

    Directions

    adults and children 2 years. and older: brush teeth thoroughly after meals or at least twice a day or as directed by a dentist.

    do not swallow

    to minimize swallowing, use a pea-sized amount in children under 6 years old

    supervise children's brushing until good habits are established

    children under 2y ears: ask a dentist before use.

  • INACTIVE INGREDIENT

    Inactive ingredients-

    calcium carbonate, calcium hydrogen phosphate, carboxymethyl cellulose, flavor, glycerin, hydrated alumina, hydrated silica, potassium sorbate, saccharin sodium, sodium lauryl sulfate, sorbitan monooleate, sorbitol, titanium dioxide, water, xanthan gum.

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    Personal Care Products, LLC

    Bingham Farms, MI 48025-2463

    Made in China

  • PRINCIPAL DISPLAY PANEL

    Advanced Whitening Anticavity Fluoride Toothpaste

    Net Wt 6.4oz (181g)

    Fresh Mint

    Fights Tarter Build-up

  • PRINCIPAL DISPLAY PANEL

    Advanced Whitening Toothpaste

  • PRINCIPAL DISPLAY PANEL

    Advanced Whitening Toothpaste

  • PRINCIPAL DISPLAY PANEL

    Advanced Whitening Toothpaste

  • INGREDIENTS AND APPEARANCE
    ADVANCED WHITENING ANTICAVITY FLUORIDE  
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-2238
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE0.76 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29500-2238-61 in 1 BOX
    1181 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35501/24/2011
    Labeler - Personal Care Products, LLC (966155082)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yangzhou Lierkang Daily Used Chemicals Co Ltd531075083manufacture
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