Label: ESOPINIO TOPAZ PHYTO- 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 August 16, 2013

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  • ACTIVE INGREDIENT

    Active Ingredient: Sodium Monofluorophosphate 0.76%

  • INACTIVE INGREDIENT

    Inactive Ingredients:
    Dicalcium Phosphodihydrate, Tocopheryl Acetate, Sodium Benzoate, d-Sorbitol, Sodium, Carboxymethylcellulose, Silica, Monosodium Phosphate, Sodium Lauryl Sulfate, Sorbitan, Monooleate, Tetrasodium Phyrophosphate, Sodium Saccharin, Xylitol, Mentha (peppermint)
    Leaf Extract, Fragrance, Salvia Officinalis (Sage) Leaf Extract, Commiphora Myrrha Extract, Cardamom Extract, Chamomilla Recutita (Matricaria) Flower Extract, Blue l, Yellow 5, Titanium Dioxide, Composite Topaz (MM-1), Water

  • PURPOSE

    Purpose:
    1. Cavity Protection
    2. Anti-plaque
    3. Whitens Teeth
    4. Breath Freshening

  • WARNINGS

    Warnings:
    If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center iimmediately. Children under 2 years, ask a dentist or physician.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children under 6 years of age.

  • INDICATIONS AND USAGE

    Indications and usage:
    1. Brush teeth thoroughly, preferably after each meal, or at least twice a day,
    2. Keep the lid tightly closed after using.
    3. Keep at a room temperature

  • DOSAGE AND ADMINISTRATION

    Dosage and Administration:
    1. Children 2 to 6 years of age: To minimize swallowing, use only a pea sized amount and supervise child's brushing until good habits are established.
    2. Children under 2 years: Ask your dentist or physician.
    3. Adults and children 2 years and older: Brush teeth thoroughly, preferably after each meal, or at least twice a day.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    ESOPINIO TOPAZ PHYTO 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44781-230
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Monofluorophosphate (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.91 g  in 120 g
    Inactive Ingredients
    Ingredient NameStrength
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44781-230-01120 g in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35506/01/2013
    Labeler - ZION SYNTHETIC FIBER CO., LTD. (688011147)
    Registrant - ZION SYNTHETIC FIBER CO., LTD. (688011147)
    Establishment
    NameAddressID/FEIBusiness Operations
    ZION SYNTHETIC FIBER CO., LTD.688011147manufacture(44781-230)