Label: NEW DOCTOR AG PLUS GOLD- 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 February 25, 2011

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT: Sodium Monofluorophosphate

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:

    D-Sorbitol, Glycerin, Sodium  Saccharin, Chitosan, Xylitol, Sodium Lauryl Sulfate, Menthol, Peppermint, Sodium Benzoate, Green tea extract, Sodium Carboxyl Cellulose,
    Siver, Water, Triclosan, Siliccon Dioxide

  • PURPOSE

    PURPOSE: ANTICAVITY

  • WARNINGS

    WARNINGS:
    WHEN USING THIS PRODUCT DO NOT USE FOR SENSITIVITY LONGER THAN FOUR WEEKS UNLESS RECOMMENDED BY A DENTIST.
    STOP USE AND ASK A DENTIST IF THE SENSITIVITY PROBLEM PERSISTS OR WORSENS.
    SENSITIVE TEETH MAY NEED PROMPT CARE.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN:

    IF ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • INDICATIONS & USAGE

    INDICATION AND USAGE:

    ADULTS AT LEAST A HALF-INCH STRIP OF THE PRODUCT ONTO A SOFT BRISTLED TOOTH BRUSH.
    BRUSH TEETH THOROUGHLY FOR AT LEAST 3 MINUTES TWICE A DAY (MORNING AND EVENING)
    UNDER 12 YRS: ASK A DENTIST

  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION:

    ADULTS AT LEAST A HALF-INCH STRIP OF THE PRODUCT ONTO A SOFT BRISTLED TOOTH BRUSH.
    BRUSH TEETH THOROUGHLY FOR AT LEAST 3 MINUTES TWICE A DAY (MORNING AND EVENING)
    UNDER 12 YRS: ASK A DENTIST

  • PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    NEW DOCTOR AG PLUS  GOLD
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75984-001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE0.15 g  in 150 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    MENTHOL (UNII: L7T10EIP3A)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SILVER (UNII: 3M4G523W1G)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75984-001-01150 g in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35509/01/2010
    Labeler - HANIL PHARMACEUTICAL CO., LTD. (688197087)
    Registrant - HANIL PHARMACEUTICAL CO., LTD. (688197087)
    Establishment
    NameAddressID/FEIBusiness Operations
    HANIL PHARMACEUTICAL CO., LTD.688197087manufacture
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