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Dental plus Regular Flavor (Tropical International Manufacturing Inc)

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Dosage Form Package Information Links
PASTE, DENTIFRICE 1 TUBE in 1 CARTON (62678-217-17) > 200 g in 1 TUBE Label Information

Complete Dental plus Regular Flavor Information

  • SPL UNCLASSIFIED SECTION

    Drug facts


  • Active Ingredient

    Sodium Monofluorophosphate 0.8% (1000 ppm F)


  • Purpose

    anticavity


  • Use

    For cavity prevention and tooth protection.


  • Warnings


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

    If more than used for brushing is accidentally swallowed, get medical help or contact a poison control center right away.


  • SPL UNCLASSIFIED SECTION


    Drug Facts (continued)

    Dental plus Regular Flavor 200 g


  • Directions










    Adults and children 2 years of age and older
    Children 2 to 6 years

    Children under 2 years
    Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by dentist or physician.
    Use only a pea-sized amount and supervise child brushing and rinsing (to minimize swallowing)
    Ask a dentist or a physician


  • Inactive ingredients

    Water, Sorbitol, Calcium Carbonate, Silica, Sodium Lauryl Sulphate, Flavor, Cellulose Gum, Sodium saccharin, Sodium Benzoate.


  • Questions? Comments?

    call toll-free 1-888-777-8767. Monday-Friday 9am-5pm


  • SPL UNCLASSIFIED SECTION

    Made by Tropical Degil Cosmetics

    Ind. Ltd. Kiryat Shmona, Israel for

    Tropical International Cosmetics, Inc.

    18 Stewart Street,

    Brooklyn, NY 11207 USA

    Made in Israel


  • PRINCIPAL DISPLAY PANEL - 7 oz Tube

    ANTICAVITY FLUORIDE TOOTHPASTE

    FIGHTS CAVITIES and TOOTH DECAY

    Tropical DEGIL Dental plus REGULAR FLAVOR

    NEW GIANT SIZE STAND UP TUBE

    GREAT TASTING MINT FLAVOR

    NET WT. 7 OZ (200 G)

    Principal Display Panel - 7 oz Tube



  • INGREDIENTS AND APPEARANCE
    DENTAL PLUS REGULAR FLAVOR 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:62678-217
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE 8 mg  in 1 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62678-217-17 1 in 1 CARTON
    1 200 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 05/19/2010
    Labeler - Tropical International Manufacturing Inc (962685884)
    Establishment
    Name Address ID/FEI Business Operations
    Tropical Degil Cosmetics Industries LTD 600437230 manufacture, label, pack, analysis