Home > Drugs A-Z > DENBLAN

DENBLAN (DARPHIN DIST.)

Available Formats

Dosage Form Package Information Links
PASTE, DENTIFRICE 1 TUBE in 1 CARTON (16555-996-01) > 75 mL in 1 TUBE Label Information

Complete DENBLAN Information

  • 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 Type HUMAN OTC DRUG Item Code (Source) NDC:16555-996
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE 0.76 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:16555-996-01 1 in 1 CARTON
    1 75 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part355 08/01/2004
    Labeler - DARPHIN DIST. (105157494)
    Establishment
    Name Address ID/FEI Business Operations
    ELGC Kabushiki Kaisha 712808195 RELABEL, REPACK
    Establishment
    Name Address ID/FEI Business Operations
    Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE, RELABEL, REPACK
    Establishment
    Name Address ID/FEI Business Operations
    ARAMIS, INC 042918826 MANUFACTURE
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS DISTRIBUTION CENTER 208579636 RELABEL, REPACK
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS, LTD 253616536 MANUFACTURE
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS, LTD 255175580 MANUFACTURE
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS, LTD. 205952385 MANUFACTURE
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER N.V. 370151326 MANUFACTURE
    Establishment
    Name Address ID/FEI Business Operations
    LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE
    Establishment
    Name Address ID/FEI Business Operations
    NORTEC KEYSTONE 787336577 MANUFACTURE, RELABEL, REPACK
    Establishment
    Name Address ID/FEI Business Operations
    NORTHTEC BRISTOL 949264774 MANUFACTURE, RELABEL, REPACK
    Establishment
    Name Address ID/FEI Business Operations
    NORTHTEC KEYSTONE 618107429 MANUFACTURE, RELABEL, REPACK
    Establishment
    Name Address ID/FEI Business Operations
    WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE
    Establishment
    Name Address ID/FEI Business Operations
    Aveda Corporation 071352058 MANUFACTURE
    Establishment
    Name Address ID/FEI Business Operations
    CCI Productions Parfums & Cosmetiques 268298408 MANUFACTURE