Label: DENBLAN WHITENING FORMULA ANTI CAVITY 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 1, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium monofluorophosphate 0.76%

  • Purpose

    Fluoride toothpaste

  • Use

    Aids in the prevention of dental cavities.

  • Warnings

    Keep out of 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.

  • Directions

    • Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
    • Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).
    • Supervise children as neccessary until capable of using without supervision.
    • Children under 2 years of age: Consult a dentist or doctor.
  • Ingredients

    water, dicalcium phosphate, calcium carbonate, silica, glycerin, sorbitol, algin, carica papaya (papaya) fruit extract, ananas sativus (pineapple) fruit extract, mentha viridis (spearmint) leaf oil, mentha arvensis leaf oil, usnea barbata (lichen) extract, angelica archangelica root oil, carum petroselinum (parsley) seed oil, foeniculum vulgare (fennel) oil, sodium lauryl sulfate, propylene glycol, sodium saccharin, limonene, sodium benzoate, sodium propylparaben, sodium methylparaben <ILN36886>.

  • SPL UNCLASSIFIED SECTION

    DARPHIN
    LABORATORIES DARPHIN, Dist.

  • PRINCIPAL DISPLAY PANEL - 75mL Carton

    WHITENING FORMULA
    DENBLAN
    ANTICAVITY FLUORIDE TOOTHPASTE

    REFRESHING MINT TASTE

    e 75mL
    POIDS NET WT. 2.6 OZ.

    Principal Display Panel - 75mL Carton
  • INGREDIENTS AND APPEARANCE
    DENBLAN   WHITENING FORMULA ANTI CAVITY FLUORIDE
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16555-996
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE0.76 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    PAPAYA (UNII: KU94FIY6JB)  
    PINEAPPLE (UNII: 2A88ZO081O)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)  
    USNEA BARBATA (UNII: D6DVA9TCAP)  
    ANGELICA ROOT OIL (UNII: B25G881UOX)  
    PARSLEY SEED OIL (UNII: XB8Q500O0Z)  
    FENNEL OIL (UNII: 59AAO5F6HT)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
    METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16555-996-011 in 1 CARTON
    175 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35508/01/2004
    Labeler - DARPHIN DIST. (105157494)
    Establishment
    NameAddressID/FEIBusiness Operations
    ELGC Kabushiki Kaisha712808195RELABEL, REPACK
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE, RELABEL, REPACK
    Establishment
    NameAddressID/FEIBusiness Operations
    ARAMIS, INC042918826MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636RELABEL, REPACK
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD255175580MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER N.V.370151326MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTEC KEYSTONE787336577MANUFACTURE, RELABEL, REPACK
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC BRISTOL949264774MANUFACTURE, RELABEL, REPACK
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC KEYSTONE618107429MANUFACTURE, RELABEL, REPACK
    Establishment
    NameAddressID/FEIBusiness Operations
    WHITMAN LABORATORIES, LTD.216866277MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Aveda Corporation071352058MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    CCI Productions Parfums & Cosmetiques268298408MANUFACTURE
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