Label: DENTAL PLUS WHITENING- 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 May 19, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium Monofluorophosphate 0.8% (1,000 ppmF)

  • Purpose

    anticavity

  • Use

    For cavity prevention, Tooth Protection and Whiter Teeth.

  • 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 Whitening 172g

  • 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, PEG-32, Sodium Lauryl Sulphate, Cellulose Gum, Sodium Bicarbonate, Flavor, Titanium Dioxide, Sodium Saccharin, Sodium Benzoate, Zinc Citrate

  • 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 - 6 oz Tube

    ANTICAVITY FLUORIDE TOOTHPASTE

    Tropical DEGIL Dental plus Whitening

    FOR HEALTHY AND BRIGHT TEETH

    NET WT.6 OZ (172 G) Cont. Neto: 6 oz (172 G)

    Principal Display Panel - 6 oz Tube

  • SPL UNCLASSIFIED SECTION

    For best results, squeeze tube from

    the bottom and flatten as you go up

  • INGREDIENTS AND APPEARANCE
    DENTAL PLUS WHITENING 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62678-216
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE8 mg  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62678-216-161 in 1 CARTON
    1172 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35505/19/2010
    Labeler - Tropical International Manufacturing Inc (962685884)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tropical Degil Cosmetics Industries LTD600437230manufacture, label, pack, analysis
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